| CTRI Number |
CTRI/2025/11/096889 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment of hypothyroidism with ayurveda medicine Ghanadi vati & Kanchnara gudika |
|
Scientific Title of Study
|
A RANDOMIZED CLINICO-COMPARATIVE TRAIL TO
EVALUATE THE EFFICACY AND SAFETY OF GHANADI VATI
AND KANCHNARA GUDIKA IN THE MANAGEMENT OF
DHATVAGNIMANDYA W.S.R. 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 Divya singh charan |
| Designation |
Ph.D Scholar |
| Affiliation |
Maharao Skekhaji Regional Ayurveda Research Institute Bani Park,Jhotwara road, Jaipur |
| Address |
Kayachikitsa department,OPD-1(Room no-1)
Mahatma Jyotiba Fule Ayurveda Mahavidyalaya Chomu, Jaipur
Room no-11C,Maharao Skekhaji Regional Ayurveda Research Institute Bani Park,Jhotwara road, Indra colony
Jaipur
Jodhpur
RAJASTHAN
303702
India |
| Phone |
09828770266 |
| Fax |
|
| Email |
divyacharan.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Jain |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Maharao Skekhaji Regional Ayurveda Research Institute |
| Address |
Room no-11C, Maharao Skekhaji Regional Ayurveda Research Institute Bani Park,Jhotwara road, Indra colony
Jaipur
-
Jaipur
RAJASTHAN
302016
India |
| Phone |
7425063398 |
| Fax |
|
| Email |
vaidyaakjain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya singh charan |
| Designation |
Assistant professor |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan ,jodhpur,pincode 342037 |
| Address |
Kayachikitsa department opd no -1 Mahatma Jyotiba Fule Ayurveda Mahavidyalaya Chomu, Jaipur
-
Jaipur
RAJASTHAN
303702
India |
| Phone |
9828770266 |
| Fax |
|
| Email |
divyacharan.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Divya Singh Charan |
| Address |
Kayachikitsa department opd-1,Mahatma jyotiba fule ayurveda mahavidyalaya Chomu, Jaipur
303702 |
| Type of Sponsor |
Private medical college |
|
|
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 Divya singh charan |
Maharo skekhaji regional ayurveda research institute Bani park jhotwara road indra colony jaipur |
Roomno-11c,Maharo skekhaji regional ayurveda research institute Bani park jhotwara road indra colony jaipur
Jaipur
RAJASTHAN |
09828770266
divyacharan.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee M.S.Regional Ayurveda Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: AGNIVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ghanadi vati , Reference: Bhaisajya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Chapter-10 Agnimandhya
shlok no- 300-302 | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchnar gudika, Reference: Bhaisajya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Chapter no-44 Galganda adhyaye
Shlok no -60-62 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptom of Dhatwagnimandya (Hypothyroidism) will be selected for the present study. Patients having age between 18 to 60 years of either sex.Already diagnosed and Fresh patients of TSH level 5-12 mlU/L. Patients, willing to give written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have TSH levels more than12 mlU/L. congenital hypothyroidism and secondary hypothyroidism. any type of thyroid surgery.Patients below 18 years and above 60 years of age. uncontrolled Diabetes mellitus. poorly controlled hypertension. clinical evidence of Heart failure.Other exclusion includesAlcoholics and/or drug abusers.
Pregnant/lactating woman. Any other condition which the Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary outcomes are Any changes in the value of serum TSH. |
Total study time 90days follow up at every 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in T3 & T4.
Changes in status of Agni (Jatharagni Assessment).Change in RAND 36- Item Health Survey 1.0 Questionnaire.
Change in Swasthya Assessment Scale. |
at base line,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a randomized, prospective, open-label, interventional comparative clinical trial. The trial consists of three groups: one will receive Ghanadi Vati, the second group will receive Kanchnara Gudika and the third group will receive both Ghanadi Vati,and Kanchnara Gudika together |