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CTRI Number  CTRI/2022/04/041594 [Registered on: 01/04/2022] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF SHATPUSHPA CHURNA, DHANYAK SHUNTHI PANIYA AND AYURVEDIC DIETARY AND LIFESTYLE MODIFICATION IN MANDAGNI WITH SPECIAL REFERENCE TO SUBCLNICAL HYPOTHYROIDISM. 
Scientific Title of Study   A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF SHATPUSHPA CHURNA, DHANYAK SHUNTHI PANIYA AND NIDANA PARIVARJAN IN MANDAGNI WITH SPECIAL REFERENCE TO SUBCLINICAL HYPOTHYROIDISM. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DEEP MALA 
Designation  PG SCHOLAR 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN 
Address  DEPARTMENT OF KAYACHIKITSA NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR NEAR JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR NEAR JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302002
India 
Phone  7018659647  
Fax    
Email  deep.choba24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RASHMI MUTHA 
Designation  ASSISTANT PROFESSOR  
Affiliation  NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN 
Address  DEPARTMENT OF KAYACHIKITSA NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR NEAR JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN
DEPARTMENT OF KAYACHIKITSA NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR NEAR JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302002
India 
Phone  7976512056  
Fax    
Email  rashmimutha21@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR DEEP MALA 
Designation  PG SCHOLAR  
Affiliation  NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN 
Address  DEPARTMENT OF KAYACHKITSA NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR NEAR JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR NEAR JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302002
India 
Phone  7018659647  
Fax    
Email  deep.choba24@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR 
Address  JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DEEP MALA  NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR  DEPARTMENT OF KAYACHKITSA NATIONAL INSTITUTE OF AYURVEDA JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN 302002
Jaipur
RAJASTHAN 		 7018659647

deep.choba24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:, Apathya:
2Intervention ArmDrugClassical(1) Medicine Name: dhanyak shunthi paniya, Reference: sharangdhara samhita madhyam khand kwath kalpana (2/65), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1500(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: dhanyak shunthi paniya lkalpana 1.5l to drink for whole day
3Intervention ArmDrugClassical(1) Medicine Name: shatpushpa churna, Reference: Bhavprakash Nighantu Naritikyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between the age of 18-60 years of either sex.
2. Patients with subclinical hypothyroidism with TSH levels ranging from 5.5µIU/ml - 20µIU/ml.
3. k/c/o Subclinical Hypothyroidism but still not taking Levothyroxine therapy.
4. Patients willing to take Ayurvedic medicine and sign the consent form.
5. Patients having symptoms of Mandagni. 
 
ExclusionCriteria 
Details  1. TSH level above 20 µIU/ml.
2. Patients already under Levothyroxine therapy.
3. Patients suffering from congenital hypothyroidism, overt hypothyroidism, and secondary hypothyroidism.
4. Patients of hyperthyroidism, neoplasia, toxic goitre are excluded.
5. Patients who have undergone any type of thyroid surgery.
6. Patients suffering from systemic diseases like cardiac problems, diabetes, carcinomas etc.
7. Patients taking drugs known to alter thyroid hormone level (e.g., Amiodarone)
8. Patients who are pregnant or expecting pregnancy in next six months.
9. Recent hospitalization for major illness, to exclude with ESS (Euthyroid Sick Syndrome).

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in TSH value  60 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the symptoms of Mandagni
Change in general sign and symptoms associated with subclinical hypothyroidism.
Reduction in Body weight and BMI
 		 60 DAYS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) 15/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Subclinical hypothyroidism (SCH) is biochemically defined as an elevated level of thyroid stimulating hormone (TSH) with normal level of free thyroxine (FT4) in the blood with minimal or no signs and symptoms of thyroid dysfunction. The most common cause of subclinical hypothyroidism is chronic autoimmune thyroiditis associated with antithyroid peroxidase antibodies (Hashimoto’s thyroiditis) but it can also occur due to other causes. Subclinical hypothyroidism can be classified as Mild Grade 1 SCH (upper limit of TSH 9.9 mIU/L) and severe grade 2 SCH (TSH ≥10mIU/L). Individuals with subclinical hypothyroidism are often asymptomatic, but clinical manifestations similar to overt hypothyroidism are present in milder form. Several meta-analyses of observational studies have revealed an association between SCH and coronary artery diseases.
There is no direct description of hypothyroidism or subclinical hypothyroidism  in Ayurvedic texts. There are many diseases which are not mentioned directly in Ayurveda texts and are called as Anukta vikar. Subclinical hypothyroidism is one of such disease. According to Acharya Charak,  it is not possible to name every disease but it is important to understand the possible pathogenesis of the disease in terms of Dosha, Dhatu, Mala & Agni because the vitiated Doshas due to difference in Nidana give rise to different disease at different places. Therefore, if a physician understands the Prakriti, Adhishthan and Samuthan vishesha of the disease it can be managed successfully.

On reviewing literature on SCH, it has been found that Subclinical Hypothyroidism in Ayurveda has been correlated with terms like Agnimandhya, Dhatwaagnimandhya, Raspradoshajvikara and Avranjanya vikara, the root cause of all these disorders being abnormality of Agni. However, there is a lack of scientific studies establishing an association of status of Agni and SCH.  With all these points in mind the current study has been planned with an aim to estimate the prevalence of Agnivaishamya in patients with Subclinical hypothyroidism and to study the effect of Agnideepan chikitsa in patients of Subclinical hypothyroidism with Mandagni.

In this study patients of subclinical hypothyroidism will be interviewed and an assessment of Agni will be done using Agni assessment questionnaire and Patients of subclinical hypothyroidism with Mandagni will be enrolled to study the effect of Shatpushpa Churna, Dhanyak Shunthi Paniya and Nidana Parivarjana on TSH level and symptoms of Mandagani. 
 
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