An explorative clinical study to evaluate the combined effect of Nirgundi...

[Full title: An explorative clinical study to evaluate the combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna in the management of Hypothyroidism]

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ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 26 An explorative clinical study to evaluate the combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna in the management of Hypothyroidism Sindhujakavya Veerashetti 1 , Mythrey R.C 2 1 Final year PG Scholar, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India. 2 Professor, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India. I NTRODUCTION Hypothyroidism is a very common disorder of thyroid gland, with reduced production of thyroid hormones, [1] it is the commonest functional disorder of the thyroid gland. Commonly seen symptoms are tiredness, weakness, dry skin, feeling cold, hair loss, Address for correspondence: Dr. Sindhujakavya Veerashetti Final year PG Scholar, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India. E-mail: amarappa 76@gmail.com Submission Date: 1/00/2021 Accepted Date: 00/00/2021 Access this article online Quick Response Code Website: www.jaims.in DOI: 10.21760/jaims.6.5.4 difficulty in concentration and poor memory, constipation, weight gain with poor appetite etc. Prevalence of hypothyroidism in India is around 10.95% and females are more sufferers than males with ratio 6:1 [2] In the present study hypothyroidism was analysed based on the Dosha, Dushya, Sthana, Srotas and Agni , by comparing the signs and symptoms of hypothyroidism. Kapha and Vata are the main Dosha involved in the pathology. Most of the symptoms of hypothyroidism are similar to that of Kapha Vata Vriddhi, Pitta Kshaya and Agnimandya which further leads to Dhatvagni Mandhya, Rasa and Medha Dhatu Dushti . The main organ involved is thyroid gland. It is located at the base of the neck which belongs to Jatrurdhwa as per Ayurveda. Hence the intervention adopted in the study was Nasya , as Nasya Karma is the main treatment A B S T R A C T Backgroud: Hypothyroidism is a hypometabolic clinical state, resulting from the reduction of thyroid hormone functions in the body. Prevalence of hypothyroidism in India is around 10.95% and females are more sufferers than males with ratio 6:1. Prevalence of subclinical hypothyroidism is 6 to 8% in women, 3% in men, and annual risk of developing clinical Hypothyroidism is about 4%. By observing the increasing incidence of hypothyroidism, this study was conducted as an attempt for finding better treatment protocol through the heritage of Ayurveda. Objective of the study: To evaluate the combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna with Shigrupatra Kwatha in the management of hypothyroidism. Materials and Methods: A single group open clinical study with pre-post test design was carried out in Government Ayurveda Medical College and Hospital, Mysuru and through conducting special camps. Data was collected as per the proforma prepared for the purpose of the study Nasya Karma with Nirgundi Taila for 7 days , Chopachinyadi Choorna with Shigru Patra Kwatha as Anupana for 60 days were taken as intervention. The data was analysed using descriptive and inferential statistics. Results: The result on TSH value of 30 subjects after the intervention showed statistically non significant result with p value 0.067. Result on Zulewski’s clinical score for hypothyroidism showed statistically highly significant result with p value 0.000 Conclusion: The intervention used in the study was more effective in reducing the symptomatology of Hypothyroidism, than normalizing the TSH value. Key words: Nirgundi Taila Nasya, Chopachinyadi Choorna, Shigrupatra Kwatha, Hypothyroidism.

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Sindhujakavya Veerashetti et al. Combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna ISSN: 2456-3110 ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 27 modality for Jatrurdhvavyadhi. Chopachinyadi Choorna (an indigenous formulation) having drugs of Kapha Vatahara , Agnideepana , Pachana, Balya, Lekhana and Medhya properties, was administered along with Shigrupatra Kwatha as Anupana which may help in reducing signs and symptoms of hypothyroidism. O BJECTIVE OF THE STUDY To evaluate the combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna with Shigru Patra Kwatha in the management of hypothyroidism M ATERIALS AND M ETHODS The materials used in the study were Nirgundi Taila [4] for Nasyakarma contains Nirgundi Patra Swarasa, Langali Moola, Tila Taila [5,6] The ingredients of Chopachinyadi choorna is mentioned in below table Table 1: Showing the ingredients of Chopachinyadi Choorna [7-14] along with Shigrupatra [15] Kwatha as Shamanoushadhi. Vacha 1 part Katuki 10 parts Chopachini 30 parts Ashwagandha 30 parts Trikatu 30 parts Kanchanara 30 parts Source of drug and method of preparation Nirgundi Taila, Chopachinyadi Choorna, Shigru Patra Kwatha Choorna were specifically prepared for the purpose of the study and procured from K.V.G Ayurveda Pharma and Research Centre, Sullia (a GMP certified company). Methods Method of collection of data a) Study design It was a single group open clinical trial with pre-posttest design b) Sample size A total of 34 subjects were registered for the study, there were 4 dropouts and the study was completed in 30 subjects. The data was collected as per the case sheet pro forma designed for the study and informed written consent was taken. c) Duration of study: 60 days Inclusion criteria 1 Subjects belonging to age group of 18 to 50 years of all gender were included. 2 Subjects with the TSH value > 5.5 mIU/L to < 25 mIU/L 3 Subjects with elevated level of TSH which may or may not be associated with the reduced value of T 3 and T 4 . 4 Both fresh and treated cases of hypothyroidism were included. A - Freshly detected and untreated cases of hypothyroidism. B - Established and treated cases of hypothyroidism also who were ready to discontinue the earlier medication. A flush out period of about 10 days was allowed before the intervention. Exclusion criteria 1 Subjects with congenital hypothyroidism, chronic history of hypothyroidism (>5 yrs.) and secondary hypothyroidism. 2 Subjects with any systemic illnesses which interrupt the present intervention. 3 Subjects who had undergone thyroid surgery. 4 Pregnant and lactating women were excluded. 5 Diagnosed cases of neoplastic conditions, toxic goitre was also excluded. Diagnostic criteria Objective criteria Lab investigation: Thyroid profile with TSH >5.5 m IU/L to < 25 mIU/L may or may not be associated with the reduced value of T 3 and T 4 .

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Sindhujakavya Veerashetti et al. Combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna ISSN: 2456-3110 ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 28 Subjective criteria Subjects who may or may not had any of these complaints along with raised TSH value. Symptoms 1 Tiredness, weakness 2 Dry skin 3 Feeling colds 4 Hair loss 5 Difficulty in concentrating and poor memory 6 Constipation 7 Weight gain with poor appetite 8 Hoarse voice 9 Menorrhagia (later oligomenorrhea/amenorrhea) 10 Paraesthesia 11 Dyspnoea 12 Impaired hearing Signs 13 Dry coarse skin 14 Cool peripheral extremities 15 Puffy face 16 Diffused alopecia 17 Bradycardia 18 Peripheral oedema 19 Delayed tendon reflex 20 Carpel tunnel syndrome Assessment Criteria 1 The TSH value was assessed before and after intervention 2 Zulewski’s clinical score for hypothyroidism [16] Table 2: Shows the Zulewski’s clinical score for hypothyroidism. On the basis of Symptoms New score Present Absent 1 Diminished sweating 1 0 2 Hoarseness 1 0 3 Dry skin 1 0 4 Constipation 1 0 5 Weight increase 1 0 6 Paraesthesia 1 0 7 Impairment of hearing 1 0 Physical signs 1 Coarse skin 1 0 2 Cold skin 1 0 3 Periorbital puffiness 1 0 4 Slow movements 1 0 5 Delayed ankle reflex 1 0 Sum of all symptoms and signs present: 12 A score of >5 points define hypothyroidism, while a score of 0-2 points defines euthyroidism. Assessment schedule In this study, total 2 assessments were done. Pre-test assessment: Before starting the intervention (0 th day) Post-test assessment: After the completion of intervention (61 st day) Statistical methods The results were analysed by using descriptive statistics and paired sample t test using SPSS for window software. Investigation Thyroid function test was done before and after intervention. Intervention Nasya Karma Nasya Karma was carried out as per classical method, by instilling 2 Bindu (1 ml) of Nirgundi Taila in each nostril for first 7 consecutive days of the intervention in the morning (between 8:00 am to 10:00 am) on empty stomach.

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Sindhujakavya Veerashetti et al. Combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna ISSN: 2456-3110 ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 29 Shamanoushadhi Chopachinyadi Choorna Subjects were administered 12 gm of Chopachinyadi Choorna and 50 ml of Shigrupatra Kwatha per day in 2 equally divided doses i.e., 6 gm in each dose with 25 ml of Shigrupatra Kwatha in each dose before food. O BSERVATIONS Age - Among 34 registered subjects 11 belonged to age group of 18 to 30 years, 13 were in the age group of 31 to 40 years, 10 were between the age group of 41 to 50 yrs. Gender - Among 34 subjects 3 were male and 31 subjects were female. Family history of hypothyroidism - 8 subjects had family history of hypothyroidism and 26 volunteers did not have family history of hypothyroidism. Fresh and treated cases - 18 subjects were freshly treated and 16 were treated cases. Mental stress - Among 34 subjects,17 subjects had history of mental stress. Agni - In 34 subjects, 19 were having Mandagni , 7 individuals had Vishamagni and 8 were having Samagni . Prakruti - Among 34 subjects, 2 were of Vata Prakruti , 17 were of Kapha Vata Prakruti , 6 subjects were of Vatapitta Prakruti , 2 were of Kapha Prakruti, 3 subjects had Pitta Kapha Prakruti and 4 were of Vatakapha Prakruti. Rasa Pradhanyata - Among 34 subjects, 10 were using Madhura Rasa Ahara in excess, Madhura and Katu Rasa Ahara was used in excess by 7 subjects, 5 volunteers were using Katu and Tiktarasa in excess, 5 subjects used Katu Rasa in excess ,1 subject preferred Madhura, Amla, Lavana, Katu Rasa, 1 subject used Amla, Lavana, Katu, Tikta Rasa in excess , 1 client used Madhura, Lavana Rasa in excess, 1 volunteer used Lavana, Katu Rasa in excess, 1 client used Amla and Katu Rasaahara more, 2 subjects used all the Rasa equally. Srotas - Among 34 registered subjects, all the 34 had the Rasava Srotodushti Lakshana , 5 individuals had Raktavaha Srotodushti , 20 subjects had Medhavaha Srotodushti , 30 had Asthivaha Srotas involvement, 9 subjects had Majjavaha Srotodushti , 15 had involvement of Swedavaha Srotas , 22 clients has Pureeshavahasrotodushti , 26 subjects had Annavaha Srotodushti , 9 had Udaka Vaha Srotodushti and 6 had involment of Pranavaha Srotas . Body mass index (BMI) - Among the 34 clients, 15 had BMI between 18 to 24 Kg/m 2 , 12 had BMI between 25 to 30 Kg/m 2 , 5 had BMI between 31 to 35 Kg/m 2 and 2 had BMI between 36 to 40 Kg/m 2 . Observations on clinical features of hypothyroidism Among 34 individuals, tiredness was present in 31 subjects, dry skin was present in 17, cold intolerance was present is 12, 31 subjects had hair loss, constipation was present in 27, weight gain was the complaint in 27 subjects, 26 had poor appetite, 6 had Menorrhagia, 4 had oligomenorrhea, 10 irregular menses, 4 did not had any menstrual disturbances, 10 had hoarseness of voice, muscle ache/stiffness was present in 20, puffiness of face or body was present in 12 individuals, difficulty in concentration and poor memory was present in 24 subjects. R ESULTS A total of 34 subjects were registered for the study, there were 4 dropouts. The results were obtained by assessing 30 subjects who have completed the study. Result on TSH Value Among 30 subjects, before intervention 17 (56.7%) subjects had TSH value between 5.5 to 10.5 m IU/L, 6 (20%) clients had TSH value between 10.6 to 15.5 m IU/L, 3 (10%) had TSH value between 15.6 to 20.5 m IU/L, 4(13.3%) individuals had TSH value between 20.6 to 25 m IU/L. After intervention 13 (43.33%) subjects had TSH value between 5.5 to 10.5 m IU/L, 8 (26.7%) had TSH value between 10.6 to 15.5 m IU/L, 5 (16.7%) had TSH value between 15.6 to 20.5 m IU/L, 3 (10%) had TSH value

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Sindhujakavya Veerashetti et al. Combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna ISSN: 2456-3110 ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 30 between 20.6 to 25 m IU/L and 1(3.33%) Subject had TSH value more than 25 m IU/L Hence the result on TSH value of 30 subjects before and after the intervention showed statistically nonsignificant result with p value 0 .067. Table 3: Shows TSH value before and intervention. TSH Range (m IU/L) Before Intervention After Intervention 5.5 - 10.5 17 (56.7%) 13 (43.33%) 10.6 - 15.5 6 (20%) 8 (26.7%) 15.6 - 20.5 3 (10%) 5 (16.7%) 20.6 - 25 4 (13.3%) 3 (10%) >25 0 1 (3.33%) Paired Differences Mean Std.Deviation t Df Sig.(2- tailed) Pair 1 score bef – score aft - 2.60567 7.51368 - 1.899 29 0.067 Illustration 1: TSH Value Distribution before and after intervention. Result on Zulewski’s clinical score for Hypothyroidism Among 30 subjects, before intervention 3(10%) had score between 0-2, 11 (36.7%) had score 3-5, 16 (53.33%) had score >5. After intervention, 16 (53.33%) individuals had score between 0-2, 14 (46.7%) had score between 3-5. Table 4: Shows Zulewski’s Clinical Score before and after intervention. Score Before Intervention After Intervention 0-2 3 (10%) 16 (53.33%) 3-5 11 (36.7%) 14 (46.7%) >5 16 (53.33%) 0 The data obtained from the 30 subjects, based on the Zulewski’s Clinical Score for Hypothyroidism before and after the intervention showed statistically highly significant result with p value 0.000. Illustration 2: Zulewski’s Clinical Score before and after intervention. Paired sample t test Mean N Std. Deviation Std. Error Mean Pair 1 score_bef 5.2000 30 1.84578 0.33699 score_aft 2.4000 30 1.27577 0.23292 Paired Differences Mean Std.Deviation T Df Sig.(2- tailed) Pair 1 score bef – score aft 2.80000 1.60602 9.549 29 0.000 0 10 20 TSH : 5.5 - 10.5 TSH : 10.6 -15.5 TSH : 15.6 -20.5 TSH : 20.6 - 25 > 25 After intervention Before intervention 0 5 10 15 20 0 to 2 3 to 5 >5 SCORE AFTER INTERVENTION SCORE BEFORE INTERVENTION Paired sample t test Mean N Std. Deviation Std. Error Mean Pair 1 TSH_bef 11.7453 30 5.30563 0.96867 TSH_aft 14.3510 30 9.46573 1.72820

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Sindhujakavya Veerashetti et al. Combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna ISSN: 2456-3110 ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 31 DISCUSSION Among the 30 subjects, in 12 individuals TSH value has been reduced from 0.2 to 6 m IU/L after intervention. It was observed that in 18 subjects TSH level was increased from 3 to 30 m IU/L after intervention. In none of the subjects TSH value was reduced to normal range after intervention. The intervention used in the present study were effective in reducing the symptoms of hypothyroidism like constipation, hoarseness, reduced sweating, dry skin, coarse skin, cold skin and periorbital puffiness. 1 to 3 kg of weight loss was found in few subjects. Nirgundi Taila Nasya and Chopachinyadi Choorna with Shigru Patra Kwatha Anupana were effective in reducing the clinical features of hypothyroidism but not effective in normalizing the TSH value. Probable mode of action of Nasya Karma In the present study Shirovirechana Nasya was taken as one of the interventions based on the Adhishtana and Dosha Pradhanyata . In hypothyroidism the main pathology is present in thyroid gland, which is situated in the Urdhvajatru . Predominant Dosha involved here are Kapha and Vata . Nasya is said to be the best treatment for Urdhvajatru Vikara . Shirovirechana type of Nasya is helpful in alleviating the Kaphaja Urdhvajatrugata Vikara . The nasal route of administration offers many advantages for local and systemic drug delivery. The nasal route presents a large surface area for drug deposition and permeation. Good vascularisation of the nasal epithelium facilitates the rapid absorption of drugs into the systemic circulation and hence provides a rapid onset of drug action. Furthermore, nasal mucosa has lower enzymatic activity than that of GI tract. Therefore, the nasal route is convenient for the administration of drugs. Drugs administered by the nasal route bypass first-pass hepatic metabolism and are absorbed directly into the systemic circulation, the bioavailability of some drugs given by this route is higher than after oral administration [17] Probable reasons for non-significant result in normalizing the TSH value. Nasya was selected as one of the interventions, with an intention that it will help in Sampraptivighatana , but the pattern of Nasya chosen in this study might not be suitable for managing hormonal imbalances, as it requires continuous monitoring to normalize the hormone levels. Apart from the study it has been observed that, one subject who has advised for Pratimarsha Nasya showed better reduction in the TSH value compared to the study subjects. Hence it is suggested that Pratimarsha type of Nasya could have been better. Limitation to identify the specific cause of hypothyroidism like either autoimmunity/iodine deficiency / iatrogenic / infiltrative disorders etc; may be one of the reasons for not getting significant result in TSH value. CONCLUSION Hypothyroidism is a hypo metabolic state resulting from the deficiency of thyroid hormones. It is not a single disease entity, but involves multiple systems. It is a condition involving Agnimandhya both at Jataragni and Dhatvagni level, along with Kapha , Vata Vriddhi , Pitta Kshaya and Rasavaha Srotodushti . To stabilize this condition a study attempt was done by administering Nirgundi Taila Nasya , Chopachinyadi Choorna with Shigrupatra Kwatha as Anupana . After the completion of intervention for 60 days, there was statistically non-significant result in normalizing the TSH levels, with p value > 0.069. However, the intervention used in the present study relieved the signs and symptoms of hypothyroidism very effectively which is proved by statistically highly significant result with p value 0.000. REFERENCES 1 Yash Pal Munjal, API Textbook of Medicine VoI, 10 th edition. Jaypee Publications. 2015;p 599.

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Sindhujakavya Veerashetti et al. Combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna ISSN: 2456-3110 ORIGINAL ARTICLE Sept-Oct 2021 Journal of Ayurveda and Integrated Medical Sciences | Sept - Oct 2021 | Vol. 6 | Issue 5 32 2 Unnikrishna. Prevelence of hypothyroidism in adult – A Epidemiological study in 8 cities of India – published at http://www.nbi,nlm.gov/pmc/articles/PMC 37 3 Kasper, Fauci, et al. Harrison’s Principles of Internal Medicine, 19 th edition,2015, Mc Graw Hill Education, 16 th part, chapter 405, p 2290. 4 Chakrapanidatta, Jagadishvaraprasad tripati, (Ed) Brahmashankara tripati, 5 th edition, 1983, Choukamba Sanskrit series office, Varanasi, Galaganda gandamala apachi granthi arbuda Chikitsaadikara 27 th shloka, p 331. 5 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 90, p 411. 6 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 226, p 1002. 7 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 114, p 445. 8 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 85, p 390. 9 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 224, p 999. 10 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 82, p 375. 11 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 113,p 519. 12 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi,98,p 448. 13 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 99,p 452. 14 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 36, p 188. 15 Sastry JLN, Illustrated Dravyaguna Vijnana, vol II, reprint 2017, Chaukhamba Orientalia, Varanasi, 24,p 139. 16 Sanjay Kalra, Sachin K. Khandelwal, Akshit Goyal - Clinical scoring scale in thyroidology: A compendium, 2011, Indian Journal of Endocrinology and Metabolism, Vol 15, supplement 2, page no. S 89 to S 94. 17 Desai Rachana and Mary lee, Gillbaldi’s drug delivery systems in pharmaceutical care, American society of health system pharmacists, 2007, part 5, pg.no 66. ******************************* How to cite this article: Sindhujakavya Veerashetti, Mythrey R.C. An explorative clinical study to evaluate the combined effect of Nirgundi Taila Nasya and Chopachinyadi Choorna in the management of Hypothyroidism. J Ayurveda Integr Med Sci 2021;5:26- 32. http://dx.doi.org/10.21760/jaims.6.5.4 Source of Support: Nil, Conflict of Interest: None declared. Copyright © 2021 The Author(s); Published by Maharshi Charaka Ayurveda Organization, Vijayapur (Regd). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc-sa/4.0), which permits unrestricted use, distribution, and perform the work and make derivative works based on it only for non-commercial purposes, provided the original work is properly cited

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