A Randomized Controlled Double Blind clinical trial to evaluate the efficacy...

[Full title: A Randomized Controlled Double Blind clinical trial to evaluate the efficacy of Vedanasthapana Mahakashaya as an anxiolytic and analgesic polyherbal drug in perioperative anorectal cases]

178 Journal of Ayurvedic and Herbal Medicine 2022; 8(3): 178-182 Research Article ISSN: 2454-5023 J. Ayu. Herb. Med. 2022; 8(3): 178-182 Received: 25-08-2022 Accepted: 16-09-2022 © 2022, All rights reserved www.ayurvedjournal.com DOI: 10.31254/jahm.2022.8308 *Corresponding author: Dr. Prem Kumar Assistant Professor, Department of Shalakya Tantra, Sriganganagar College of Ayurvedic Science and Hospital, Sriganganagar Rajasthan-335001, India Email: premneelverma@gmail.com A Randomized Controlled Double Blind clinical trial to evaluate the efficacy of Vedanasthapana Mahakashaya as an anxiolytic and analgesic polyherbal drug in perioperative anorectal cases Prem Kumar 1 , O. P. Dave 2 , Bharat Paliwal 3 1 Assistant Professor, Department of Shalakya Tantra, Sriganganagar College of Ayurvedic Science and Hospital, Sriganganagar, Rajasthan 335001, India ORCID ID: https://orcid.org/0000-0002-2666-4396 2 HOD, Department of Shalya Tantra, Parul Institute of Ayurveda & Research, Vadodara, Gujarat 391760, India ORCID ID: https://orcid.org/0000-0001-9937-3998 3 Associate Professor, Department of Anaesthesiology & Critical Care, AIIMS, Jodhpur, Rajasthan 342005, India ORCID ID: https://orcid.org/0000-0001-7588-9017 ABSTRACT Introduction: In surgery, pre-operatively anxiolytic drugs and analgesics are very essential for major or minor surgical procedures to better operative and post-operative outcomes. The Vedanasthapana mahakashaya, described by the Acharya Charaka, is a group of 10 herbs and those herbs are advocated as analgesic, and anxiolytic polyherbal composition by various text books of ayurveda. So, the aim of this study was to evaluate and compare the efficacy of the Vedanasthapana mahakashaya as an analgesic drug during post operative period and as an anxiolytic drug for pre operative anxiety. Metarials & Methods: The study was a prospective, randomized, double blind, controlled trial. 80 patients of anorectal diseases who undergone for surgical intervention were randomly allocated in one of two groups. Group-1 received Vedanasthapana mahakashaya kwath (Decoction), 30 ml orally in preoperative and postoperative period while group-2 was treated with Tab. Alprazolam 0.25 mg pre-operatively and Tab. Paracetamol 500 mg postoperatively. Anxiety was assessed on the basis of Anxiety score of Hospital Anxiety and Depression Scale (HADS) preoperatively and analgesia was assessed postoperatively by internationally validated Visual Analogue Scale. Inj. Diclofenac sodium 75 mg IM was administered as a rescue analgesic. Results: Pain - baseline pain scores were not statistically differed in both groups. Both the groups showed statistically significant reduction in pain at the end of trial period. Both were found to be significantly similar (P 0.4856) but group-1 showed more reduction in pain 84.72% (P<0.0001) than the group-2 which have 80.08% reduction in VAS score (P<0.0001) Anxiety- The values of both the groups were showing statistically significant difference at different observational intervals but the reduction was significantly higher in group-2 (P<0.0158). Conclusion: Administration of the Vedanasthapana mahakashaya decoction is effective for post operative pain relief but less effective for preoperative anxiety Keywords: Preoperative Anxiety, Postoperative Analgesia, Vedanasthapana Mahakashaya . INTRODUCTION Pain is an important subjective sensation which can be experienced by an individual in various pathological conditions. Primarily it is a safety mechanism of our body and protects body to damage in tissues by any unfavorable stimulant with a sufficient threshold. Pain can interfere with the quality of life of an individual. So, an individual wants to get rid of pain at the earliest as pain makes his life more miserable [1-3] . Postoperative pain management plays a vital role in surgical practice. After any surgical procedure, tissues get damaged and causes pain. So, analgesics are required for control of post-operative pain. Good pain control encourages early mobilization and discharge from the hospital. Inadequately treated pain in the post-operative period can lead to other side effects like apprehension, sweating, nausea and increase in pulse rate, blood pressure and loss of sleep, etc [4] . There are various allopathic medicinal formulations available to relieve the post-operative pain such as opioids, NSAIDs (nonsteroidal anti-inflammatory drugs) and prostaglandin inhibitory drugs. But these medicines are not devoid of side effects. NSAIDs are known to cause gastritis and peptic ulcer while opioids can cause euphoria and prone to addiction [5] Pre-anesthetic medication refers to the use of drugs before anaesthesia to decrease anxiety, secretions, vagal stimulation and to obtain an adequate anaesthesia for better operative and post-operative outcome [6] . In surgery, pre-operatively anxiolytic drugs and analgesics are very essential for major or minor surgical procedures but in classical literature we couldn’t find any intervention done for this special purpose. Hence, there is a need to evaluate the ayurvedic formulations as an effective medicine for preoperative

179 Journal of Ayurvedic and Herbal Medicine|July-September|2022 anxiety and for post-operative analgesia. Acharya Charak describes some herbal medicines named as Vedanasthapana mahakashaya which is a group of 10 drugs for the specific use of analgesia that is mentioned in Charak Samhita among 50 groups of mahakashaya [7] . Various text books of Ayurveda have repeatedly advocated that the contents of Vedanasthapana mahakashaya possesses sedative, analgesic, and anxiolytic properties [8-16] . So, this study was planned to evaluate and compare the analgesic and anxiolytic efficacy of Vedanasthapana mahakashaya and a safer drug for the same in patients of anorectal diseases (Haemorrhoids, fissure in ano, fistula in ano) who undergone for surgical interventions. MATERIALS AND METHODS This study was conducted in the academic hospital between academic years 2018-2019. Ethical approval: The Ethical approval was taken from the Institutional Ethical Committee of the college before commencing the study Inclusion Criteria: Total 80 Patients of 18-70 years age groups of either sex posted for surgery of anorectal disorders (Haemorrhoids, Fissure in ano and Fistula in ano) and confirming to inclusion criteria of ASA grade I & II were selected for this study. Exclusion Criteria: Patients with known hypersensitivity or contraindication to any of the drug used in this study, pregnant patients & breast feeding mothers, drug abuse patients (e.g. Alcoholic, Opioid addiction, chronic analgesic medication) patients with known renal and hepatic diseased (e.g. Impaired Renal Function, Hepatitis, Obstructive Jaundice) patients with hyper-reactive airway disorders and unable to rate their pain on VAS due to psychiatric or other reasons were excluded from the study. Study design and grouping of the patients The study was a prospective, randomized, double blind, controlled trial. The 80 patients, who had to undergone surgical procedure for anorectal diseases were randomly allocated to one of the two groups by simple random number table method (computer generated) and allocation was concealed using sealed envelope technique. Randomly allocation, drug preparation and masking, and administration to the participants was done by a person, who was not involved in the study. All the related details and data were obtained and recorded in the especially designed Performa. A written informed consent was obtained from the patients who were willing to be a part of the study. All the patients were familiarized with pain and anxiety scoring. Study drugs Group-1: Vedanasthapana mahakashaya kwath (decoction). The details of drugs of Vedanasthapana mahakashaya are mentioned in Table 1. Method of preparation of kwath (decoction) The raw material of Vedanasthapana mahakashaya was purchased from the market, washed in 4-6 times in water (except Mochrasa and Shala resin) and dried in sunlight. Coarse powdered separately and mixed in the equal proportion . The 30 gm coarse powder ( Yavkoot ) was added in 8 times water and boiled till then it reduces to 1/8 th part [17-19] . Method of drug uses Preoperatively- Patients of group-1 receiving Vedanasthapana mahakashaya kwath (Decoction) 30 ml orally, at previous night of surgery & 4 hours prior to the operation. Postoperatively- Just after surgical procedure after that 6 hourly up to 3 days of the post-operative period. Group-2: Tab Alprazolam 0.25 mg preoperatively and Tab Paracetamol 500 mg post-operatively. Method of drug uses Preoperatively- Patients of group-2 was receiving Tab Alprazolam 0.25 mg, orally, dissolved in 30 ml of lukewarm water at previous night of surgery & 4 hours prior to the operation. Postoperatively- Tab Paracetamol 500 mg, orally, dissolved in 30 ml of lukewarm water, just after surgical procedure after that 6 hourly up to 3 days of the post-operative period. Masking- To mask the treatment allocation, natural color (beetroot) was added to control drugs and drugs of both the groups were administered in a non-transparent disposable milkshake sealed cup with a straw Method of procedures All the patients were operated under local anaesthesia. During the operative phase, lord’s dilation procedure was done for fissure in ano followed by ksharsutra ligation in sentinel tags. In cases of haemorrhoids ksharsutra trans fixation and ligation was done and fistula in ano after probing ksharsutra ligation was done. Outcome Assessment Analgesia was assessed postoperatively by internationally validated Visual Analogue Scale (100 mm=10 cm) at rest at the following intervals – Immediate postoperatively (0 hour), 1 st hour, 2 nd hour, 4 th hour, 6 th hour and after completion of the 6 th hour, every 6 th hour till 3 rd day. Inj. Diclofenac sodium 75 mg IM was administered when the VAS scores crossed 4 and/or the patient demanded the rescue analgesic. The time and number of given rescue doses of Inj. Diclofenac sodium in both groups was noted in the postoperative period. Feeling of anxiety was assessed on the basis of Anxiety score of Hospital Anxiety and Depression Scale (HADS) at the following intervals – T 0 - Just before to medication, T 1 - before shifting patient to operation theatre, T 2 - At arrival in the operation room, T 3 - discharge from postoperative care room. Patients who did not know English, for them questionnaires were read out in Hindi with choice of answer. Hemodynamic parameters i.e., Blood pressure and Pulse rate both were observed before procedure in every 30 minutes from 2 hours prior to surgical procedure, during procedure at every 5 minutes and after procedure at first 4 hours on every 30 minutes then next 4 hours at the hourly interval. SPO 2 (oxygen concentration) was observed only intra operatively at 5 minutes intervals.

180 Journal of Ayurvedic and Herbal Medicine|July-September|2022 All the scores were compared directly at various observation intervals, and effects of therapy were also assessed on the basis of before and after treatment values. Total duration of surgery was noted in both groups. All patients were observed closely for any adverse effects. Patients were followed up till the three post-operative days. The overall effect of the therapy was assessed in terms as- Complete relief -75-100% relief in sign and symptoms Marked relief -50-75% relief in sign and symptoms Moderate relief -25-50% relief in sign and symptoms Unsatisfactory relief -0-25% relief in sign and symptoms Statistical analysis All the data were collected, tabulated and analyzed. Continuous variables were summarized as mean, standard deviation and standard error of meanwhile categorical variables were summarized as frequency and percentages. All the results were analyzed by using Software InStat GraphPad Instat 3 Trial and all the statistical analyses involved two-tailed tests . Microsoft word and excel have been used to generate graphs and tables, etc. For calculating inter group comparison the Mann-Whitney Test was used for nonparametric data & an Unpaired ‘t’ test for parametric data. A difference with P value < 0.05 was considered statistically significant. RESULTS Total 80 patients of Anorectal diseases (Anal fissure, Fistula in Ano & Haemorrhoids) who were undergone for surgical procedures were enrolled in the study. Demographic characteristics such as incidence of age, gender, religion, educational status, dietary pattern, socioeconomic status, occupational status and psychological & constitutional profile such as satva, sharir prakriti, sara, etc. and duration of surgery, rescue doses with time were comparable. The Pulse, Systolic/Diastolic BP and SPO 2 were also compared. The data were summarized into a master chart. The maximum no. of patients was between 21 and 30 years (35%) (Table 2). The mean age was not different between the both groups. Out of 80 cases, 58 patients were males and 22 were females. Majority of patients were having Parikartika (fissure-in-ano) 47.5%, followed by Raktarsha (bleeding haemorrhoids) 31.25%, Bhagandara (fistula in ano) 18.75% and Vatarsha (external haemorrhoids) 2.5%. 26 (77.5%) patients were literate while (18) 22.5% were illiterate. Among 80 patients 42 (52.5%) patients were having Vata-pittaja prakriti followed by 21 (26.25%) patients were having Vata-kaphaja prakriti while 17 (21.25%) patients were having Kaphapittaja prakriti. Out of 80 patients 49 (61.25%) were of Madhyama Satva followed by 22 (27.5%) were of Avara Satva and 9 (11.25%) were of Pravara Satva . Effect on Anxiety scores At the baseline, there was not any significant difference between both groups (P 0.4806). The mean score of anxiety score of Hospital Anxiety and Depression Scale reduced significantly in both the groups at different observation level of trial period (Figure-1) but group-2 (Tab Alprazolam) shows significantly much reduction in Anxiety score at the end of study than the group-1( Vedanasthapana mahakashaya decoction) (P< 0.0158) Change in anxiety score of Hospital Anxiety and Depression Scale for the trial period is shown in Table 3. Overall satisfaction or relief in symptom of anxiety in both the groups is shown in Table 4. Effect on Pain (VAS) Scores Baseline VAS scores of both the groups were have not significant difference (P >0.6785). At 1 st hour VAS scores of both groups were also statistically similar (p >0.0815). Pain scores were significantly different at 2 nd , 4 th and 30 th hr. Rest scores were not having significant difference. Between 2 nd and 4 th hr time interval there was a statistically significant difference (p<0.0001) in VAS score of both groups but reduction in VAS was higher in group-2 compared to group-1. At 6 th hr observation level reduction in VAS was greater with group-1 than the group-2 but the difference was not statistically significant (P>0.9496) (Figure-2). Both the groups showed statistically significant reduction in pain at the end of trial period. Both were found to be significantly similar (P 0.4856) but group-1 showed more reduction in pain 84.72% (P<0.0001) than the group-2 which have 80.08% reduction in VAS score (P<0.0001) (Table 5). Overall satisfaction or relief in symptom of pain in both the groups is shown in Table 6. Effect on hemodynamic parameters and SPO 2 There were no statistically significant differences found in Systolic BP, Diastolic BP, Pulse rate and SPO 2 in both groups at different observation level. Surgical procedure time and total number of rescue doses in both groups In present study there was no statistically significant difference found in surgical procedure time (P>0.3603) (Table 7) and total number of rescue doses (P>0.5329) in both groups. DISCUSSION The first objective of the present study was to determine the postoperative analgesic effect of Vedanasthapana mahakashaya decoction as compared to Tab. Paracetamol and secondary objective of this study was to determine the pre-operatively anxiolytic effect of same decoction as compared to Tab. Alprazolam in patients of anorectal diseases who were undergoing surgical interventions. The drugs Tab Alprazolam and Tab Paracetamol has been chosen for comparison with Vedanasthapana mahakashaya decoction because these are the most common standard drugs for anxiolytic action and analgesia respectively [20,21] . The demographic data like age, sex and weight was found to be comparable of study population of both groups in this study and there were no significant differences found in these parameters in both groups. The duration of surgery in both groups was statistically similar.

181 Journal of Ayurvedic and Herbal Medicine|July-September|2022 In this study, there were no majors statistically significant differences found in Systolic BP, Diastolic BP, Pulse rate and SPO 2 in both groups. Pre-operative Anxiety Present study showed that Tab Alprazolam and decoction of Vedanasthapana mahakashaya both have significant reduction in preoperative Anxiety but Vedanasthapana mahakashaya found comparatively less effective to reduce the pre-operative anxiety than the Tab. Alprazolam. A placebo-controlled study with large sample size is needed for further evolution of anxiolytic efficacy of this multi-herb drug. Post-operative Analgesia The present study reveals that both the drugs have statistically significant reduction in pain score. The patients with Vedanasthapana mahakashaya decoction had received rescue analgesic 1 hr 13 minutes prior to the patients with Tab. Paracetamol but total demanding rescue analgesic doses in each of the groups were found to be statistically similar. The onset of action of oral Paracetamol was faster than the decoction of Vedanasthapana mahakashaya and its maximum effect lasts between 4 to 6 hours after that pain score increases with paracetamol group while at the same time Vedanasthapana mahakashaya shows a continuous pain reducing effect (Figure-2) which lasts even after six hours. This denotes that the action of Vedanasthapana mahakashaya decoction take more time to start than the Tab. Paracetamol but remains to continue for more hours. Thus, the Vedanasthapana mahakashaya decoction has long-lasting effect than the Tab. Paracetamol. Overall effects of both the drugs have no significant difference that means both the drugs have similar analgesic efficacy on post-operative pain. Further studies with large samples would probably throw more light on efficacy of this herbal composition for post-operative analgesia. However, there are no such studies found, which compare this multi-herb drug with modern standard drugs. Dr. Swapnil Vitthalrao More and Prof. Dr. Shubhada R. Lonikar (2015) conducted a non-comparative study with objective to study the efficacy of Vedanasthapana mahakashaya (Ghan vati) in postoperative pain management [22] . This study found that Vedanasthapana Ghanvati has significant effect on mild to moderate post-operative pain & tenderness. Further a significant decrease in pain in the patient of osteoarthritis with uses of some of the drugs of Vedanasthapana mahakshaya was evident in a study done by Jyotirupa Sarmah et al [23] . There were no any untoward effects found in patients of both groups. Gastritis and nausea were not found in any patients of the group-1 due to the decoction. A study was conducted by Dileep kumar K. J et al in 2014 on animal model which proves that Vedanasthapana mahakashaya (in Ghanavati form) have no any significant toxic effect in Swiss albino mice even at the highest dose level 5000 mg/kg body weight [24] . So, in this study it is found that Vedanasthapana mahakashaya decoction is as effective analgesic as Tab. Paracetamol but it is significantly less effective as an anxiolytic agent than of Tab. Alprazolam. Strengths and limitations Though the study has strengths due to its randomised, double blind, control design, but it has several limitations like the baseline pain score was under mild to moderate range so the results may not apply to cases with severe pain score. There were no untoward effects found in this study with trial drug but further study with large sample size can elaborate the same. This study was done with a fixed dose of the trial drug, further study with higher dose of trial drug may show the potential analgesic effect of this herbal composition. Probable mode of action The word ‘ Vedana’ is used in Ayurveda for general sensation. It is of two types i.e. pleasant and unpleasant [25] . Pain is a subjective sensation and mostly caused by an underling pathology but it can be associated with psychological and emotional factors such as fear, anxiety and depression so in ayurveda the word ‘vedana’ denotes not only the subjective sensation of pain but also the fear and anxiety. The drugs which can establish the pleasant sensation by calming the unpleasant sensations are called as the Vedanasthapana drugs [26] . The convection and the enforcement of all the sensations of the body are enforced by the Vata [27] . but in the vitiation and outbreak of vata , these sensations are manifested in the form of anguish. That is why the pain, whether it is somewhere in the body, cannot be without Vata [28] . In this way, the Vedana is the characteristic symptom of vata outbreak, hence Vedanasthapana drugs must be the suppressor of the vata dosha , because without the vata’s balance, Vedana cannot be suppressed. Thus, the drugs of the Vedanasthapana mahakashaya are particularly having ushna veerya and snigdh guna. Among the drugs of this mahakashaya some drugs such as Katfal, Tumba, etc . are having ushna veerya and some are having snigdha properties such as Mochrasa . Due to the Snigdh and Ushna guna of these drugs, vata is being inhibited, so as the result unpleasant sensation get rid of. In context to Anxiety ( Bhaya ), the katu, ushna and snigdha properties of some of the drugs of the Vedanasthapana mahakashaya can balance the vitiated vata dosha . Then naturalised vata dosha can control the raja and tama dosha and get them to their natural state. They are also helpful in sleep due to the increase of Kapha from the snigdha guna . Thus, this process provides the relief in Anxiety ( Bhaya ). However, the vedanasthapana properties of these drugs are considered due to Prabhava of these drugs. CONCLUSION The present study shows that the Vedanasthapana mahakashaya decoction is an efficacious polyherbal composition for post-operative analgesia in patients of anorectal diseases (Haemorrhoids, fissure in ano, fistula in ano) who undergone for surgical interventions but has less anxiolytic properties compared to the standard modern medicine. It can be a good herbal alternative to Tab Paracetamol and can be used for a long period to subside pain of mild to moderate intensity without fear of any adverse effects. Acknowledgments We would like to acknowledge all the volunteers who were participated and gave the consent for the study.

182 Journal of Ayurvedic and Herbal Medicine|July-September|2022 Conflict of Interest None declared. Financial support None declared. REFERENCE 1 Davidson S. Davidson’s Principles and Practice of Medicine, 22 nd ed. Philadelphia: Churchil Livingstone Elsevier publication. 2014.pp.284. 2 Sembulingam K. Essentials of medical physiology, 6 th ed. New Delhi: Jaypee brothers medical publishers (P) ltd. 2012.pp.838. 3 Arthur C. Guyton, John E. Hall. Textbook of Medical Physiology, 13 th ed. Philadelphia: Elsevier Inc. 2016.pp.621. 4 Malek Jiri, Sevcik Pavel. Post operative pain management, 3 rd ed. Praha: Mlada fronta a.s. 2017.pp.09. 5 Tripathi KD. Essentials of Medical Pharmacology, 7 th ed. New Delhi: Jaypee brothers medical publishers (P) ltd. 2013.pp.198. 6 Williams NS, Bulstrode CJK, OConnell PR. Preoperative care including the highrisk surgical patient. Baily and Love’s Short Practice of Surgery, 27 th ed. Boca Raton: FL CRC Press. 2018.pp.262. 7 Sastri K, Chaturvedi G, editors. Charak Samhita of Agnivesha, Vidyotini, Sutrasthan, Ch. 4, Ver. 47. Varanasi: Chowkhamba vidya bhawan. 1962.pp.96. 8 Nadkarni KM. Indian Material Medica, 13 th ed., Vol. 1. Mumbai: Popular Prakashana. 1976.pp.1132. 9 Prajapati ND, Purohit SS, Sharma AK, Kumar T. A Handbook of Medicinal Plants. Jodhpur: Agrobios Hindustan Printing Press. 2007.pp.474. 10 Sharma PV. Dravyaguna Vigyan, Vol. 2. Varanasi: Chaukhambha Bharti Academy. 2018.pp.671. 11 Nadkarni KM. Indian Material Medica, 13 th ed., Vol. 1. Mumbai: Popular Prakashana. 1976.pp.828. 12 Nadkarni KM. Indian Material Medica, 13 th ed., Vol. 1. Mumbai: Popular Prakashana. 1976.pp.1104. 13 Prajapati ND, Purohit SS, Sharma AK, Kumar T. A Handbook of Medicinal Plants. Jodhpur: Agrobios Hindustan Printing Press. 2007.pp.474. 14 Prajapati ND, Purohit SS, Sharma AK, Kumar T. A Handbook of Medicinal Plants. Jodhpur: Agrobios Hindustan Printing Press. 2007.pp.424. 15 Prajapati ND, Purohit SS, Sharma AK, Kumar T. A Handbook of Medicinal Plants. Jodhpur: Agrobios Hindustan Printing Press. 2007.pp.550. 16 Duke James A. Handbook of Medicinal herbs, 2 nd ed. Boca raton: Florida. 1929.pp.684. 17 Tripathi Brahmanand. editor. Sharangadhara Samhita, Dipika hindi commentary, Madhyam Khanda, Ch.2, Ver. 99. Varanasi: Chaukhambha surbharti prakashan. 2019.pp.98. 18 Tripathi Brahmanand. editor. Sharangadhara Samhita, Dipika hindi commentary, Madhyam Khanda, Ch.2, Ver. 47-9. Varanasi: Chaukhambha surbharti prakashan. 2019.pp.94. 19 Tripathi Brahmanand. editor. Sharangadhara Samhita, Dipika hindi commentary, Madhyam Khanda, Ch.9, Ver. 03. Varanasi: Chaukhambha surbharti prakashan. 2019.pp.144. 20 Tripathi KD. Essentials of Medical Pharmacology, 7 th ed. New Delhi: Jaypee brothers medical publishers (P) ltd. 2013.pp.405. 21 Davidson S. Davidson’s Principl es and Practice of Medicine, 22 nd ed. Philadelphia: Churchil Livingstone Elsevier publication. 2014.pp.286. 22 More SV, Lonikar SR. To study efficacy of drugs of Vedanasthapna gana (Gana Vati) in post operative pain management. Ayurlog. 2015;3:01-11. 23 Sarmah Jyotirupa, Das Bhabesh. Vedanasthapak drugs and its importance in pain management. IJAMSCR. 2017;5:137-143. 24 KJ Dileep kumar, Hiremath B Bharathi, Kumar Arhanth, Shreevathsa. Acute toxicity study of Vedanasthapana ghana vati. IAMJ 2015;3:07-13. 25 Sastri K, Chaturvedi G, editors. Charak Samhita of Agnivesha, Vidyotini, Sharir sthan, Ch. 1, Ver. 133. Varanasi: Chowkhamba vidya bhawan. 1962.pp.736. 26 Sastri K, Chaturvedi G, editors. Charak Samhita of Agnivesha, Vidyotini, Sutrasthan, Ch. 4, Ver. 8. Varanasi: Chowkhamba vidya bhawan. 1962.pp.85. 27 Sastri K, Chaturvedi G, editors. Charak Samhita of Agnivesha, Vidyotini, Sutrasthana, Ch. 12, Ver. 8. Varanasi: Chowkhamba vidya bhawan. 1962.pp.215. 28 Shastri A, editor. Sushruta Samhita, Ayurvedatatvasandipika, Sutrasthana, Ch. 17, Ver. 12. Varanasi: Chaukhamba Sanskrit Sansthana. 2013.pp.94. HOW TO CITE THIS ARTICLE Kumar P, Dave OP, Paliwal B. A Randomized Controlled Double Blind clinical trial to evaluate the efficacy of Vedanasthapana Mahakashaya as an anxiolytic and analgesic polyherbal drug in perioperative anorectal cases. J Ayu Herb Med 2022;8(3):178-182. DOI: 10.31254/jahm.2022.8308 Creative Commons (CC) License- This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY 4.0) license. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. (http://creativecommons.org/licenses/by/4.0/).

Journal of Ayurvedic and Herbal Medicine|July-September|2022 Table 1: Composition of Vedanasthapana mahakashaya kwath (decoction):- (Figure-3) * Because of unavailability of Alavaluka (Prunus cerasus L ), and Vanjula (Salix tetrasperma Roxb ) these were not included in this study . Padmaka ( Prunus cerasoides D.Don ) was taken as representative of Alavaluka (Prunus cerasus L ). Table 2: Age incidence Table 3: Showing the comparative reduction in Anxiety at the end of treatment in both groups Variable Group Mean Mean diff. % Relief ± SD ± SEM P value * Sig. Anxiety BT (T 0 ) AT (T 3 ) Group 1 8.4 5.4 3.025 35.90% 2.082 0.3291 <0.0001 S Group 2 8.1 3.7 4.400 54.32% 2.716 0.4294 <0.0001 S diff.- Difference, S- Significant * Wilcoxon Matched Signed-Ranks test Table 4: Overall satisfaction or relief in symptom of anxiety at the end of treatment in both groups Observation Number of patients in Group 1 % Relief in Group 1 Number of patients in Group 2 % Relief in Group 2 Complete relief 3 7.5% 15 37.5% Marked relief 2 5% 4 10% Moderate 21 52.5% 10 25% Unsatisfactory relief 14 35% 11 27.5% TOTAL 40 100 40 100 Table 5: Showing the comparative reduction in pain at the end of treatment in both groups Variable Group Mean Mean diff. % Relief ± SD ± SEM P value * Sig. PAIN BT (0 hr) AT (72 hr) Group 1 3.470 0.5275 2.943 84.72% 0.9179 0.1451 <0.0001 S Group 2 3.440 0.6850 2.755 80.08% 1.302 0.2059 <0.0001 S Sig.- Significance , S- Significant, * (Wilcoxon matched-pairs signed-ranks test) S. No. Sanskrit Name Part used Latin name Quantity 1 Shala Resin Shorea robusta Roth 1 part 2 Katphala Bark Myrica esculenta Buch.-Ham 1 part 3 Kadamba Bark Anthocephalus indicus H.L.Li 1 part 4 Padmaka Hard wood Prunus cerasoides D.Don 2 part 5 Tumba Seed Zanthoxylum alatum Roxb. 1 part 6 Mochrasa Resin Salmalia malabarica (DC.) Schott & Endl 1 part 7 Shirisha Bark Albizia lebbeck (L.) Benth 1 part 8 Ashoka Bark Saraca indica L 1 part 9 Vanjula* - Salix tetrasperma Roxb. - 10 Alavaluka* - Prunus cerasus L - S. No. Age Group Group 1 (n =40) Group 2 (n =40) Total % 1. 10-20 2 0 2 2.5 2. 21-30 16 12 28 35 3. 31-40 7 12 19 23.75 4. 41-50 9 4 13 16.25 5. 51-60 4 6 10 12.5 6. 61-70 2 6 8 10 Total 40 40 80 100

Journal of Ayurvedic and Herbal Medicine|July-September|2022 Table 6: Overall satisfaction or relief in symptom of pain at the end of treatment in both groups Observation Number of patients in Group 1 % Relief in Group 1 Number of patients in Group 2 % Relief in Group 2 Complete relief 24 60% 22 55% Marked relief 14 35% 9 22.5% Moderate 2 5% 7 17.5% Unsatisfactory relief 0 0% 2 5% TOTAL 40 100 40 100 Table 7: Comparison of surgical procedure time in both groups Surgical Procedure Time Group 1 Group 2 Mean SD SE Mean SD SE P Value t- Value Sig. Time in minutes 25.525 3.397 0.5371 24.875 2.902 0.4588 0.3603 0.9202 NS *NS- Not significant, Sig.- Significance (T 0 - Just before to medication, T 1 - before shifting patient to operation theatre, T 2 - At arrival in the operation room, T 3 - At the time of discharge from post operative care room) Figure 1: Comparison of mean Anxiety score in both groups at different observation levels pre-operatively Figure 2: Comparison of mean VAS in both groups at different observation levels post-operatively

Journal of Ayurvedic and Herbal Medicine|July-September|2022 Figure 3: Various row ingredients of Vedanasthapana mahakashaya kwath (decoction)

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