| CTRI Number |
CTRI/2026/01/101913 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study on the Benefits of Adding an Ayurvedic Herbal Medicine to Standard Thyroid Treatment in Hypothyroidism |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY ADJUVANT EFFECT OF
INDRAVARUNI MOOL CHURNA WITH LEVOTHYROXINE IN GALAGANDA WITH SPECIAL
REFERENCE TO HYPOTHYROIDISM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Sudhakar Wasnik |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422402
India |
| Phone |
8847756369 |
| Fax |
|
| Email |
sakshiwasnik03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiraman Warungase |
| Designation |
HOD and professor |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422402
India |
| Phone |
9420364157 |
| Fax |
|
| Email |
hiramanwarungase@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Sudhakar Wasnik |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL |
| Address |
Department of Kayachikitsa SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA
422402
India |
| Phone |
8847756369 |
| Fax |
|
| Email |
sakshiwasnik03@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Wasnik |
| Address |
SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon Tal.Igatpuri Dis Nashik 422402 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Sudhakar Wasnik |
SMBT AYURVED COLLEGE AND HOSPITAL |
OPD No. 20
Department of Kayachikitsa SMBT AYURVED COLLEGE AND HOSPITAL Dhamangaon, Igatpuri, Nashik
Nashik
MAHARASHTRA |
08847756369
sakshiwasnik03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT AYURVED COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Indravaruni Mool Churna, Reference: Bhav Prakash Purva Khanda, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Classical | | (1) Medicine Name: Levothyroxine, Reference: K D Tripathi, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 25(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Dose 25-100mcg | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age group between 18-60 years of either sex.
Patient fulfilling the laboratory diagnosis of hypothyroidism based on the
levels of serum TSH, T3, and T4.
Patients having TSH level less than 20 mIU/L
Patients having uncontrolled TSH level in spite adequate doses of levothyroxine(dose 25 mcg-100mcg)
Patients having signs and symptoms of hypothyroidism |
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with uncontrolled diabetes mellitus, ischemic heart disease, uncontrolled hypertension, myocardial infarction, cerebrovascular incidents, cardiac arrhythmias,and patients with active malignant diseases were not included in the study.
Lactating and pregnant women
Patients having TSH level greater than 20mIUL.
Recent thyroid surgery.
Patients taking dose of levothyroxine 100mcg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To study the adjuvant effect of indravaruni moola churna with levothyroxine on galaganda |
0th 7th 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY ADJUVANT EFFECT OF
INDRAVARUNI MOOL CHURNA WITH LEVOTHYROXINE IN GALAGANDA WITH SPECIAL
REFERENCE TO HYPOTHYROIDISM Introduction- The thyroid gland regulates growth, development, and metabolism through T3 and T4 hormones, and hypothyroidism—common in India—results from their deficiency, leading to reduced metabolic activity and myxedema. In Ayurveda, hypothyroidism correlates with Galganda, caused by Kapha and Vata vitiation with Agnimandya. This study aims to assess the adjuvant effect of Indravaruni mool churna, a Kapha-Pittahara drug, in managing Galganda with special reference to hypothyroidism Null hypothesis
There is no adjuvant effect of Indravaruni mool churna with levothyroxine in galaganda
with special reference to Hypothyroidism Alternate hypothesis
There is adjuvant effect of Indravaruni mool churna with levothyroxine in galaganda
with special reference to Hypothyroidism
|