| CTRI Number |
CTRI/2026/01/100147 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“The aim is to help people with low thyroid problems feel better and live a healthier life by improving thyroid function with the Ayurvedic medicine Dadimadi Ghrita.” |
|
Scientific Title of Study
|
Effect of dadimadi ghrutha in primary hypothyroidism |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2796455 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumy C R |
| Designation |
2nd year PG Scholar |
| Affiliation |
Goverment ayurveda collegeTripunithura |
| Address |
Department of kayachikitsa
Govt ayurveda college
Tripunithura
Eranakulam dist
Kerala state
Ernakulam
KERALA
682301
India |
| Phone |
9995906068 |
| Fax |
|
| Email |
sumyshijuraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindu P R |
| Designation |
Associate professor |
| Affiliation |
Goverment ayurveda collegeTripunithura |
| Address |
Department of kayachikitsa
Govt ayurveda college
kannur
Ernakulam
KERALA
682301
India |
| Phone |
7907112674 |
| Fax |
|
| Email |
drbindhuprasanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bindu P R |
| Designation |
Associate professor |
| Affiliation |
Goverment ayurveda collegeTripunithura |
| Address |
Department of kayachikitsa
Govt ayurveda college
Kannur
KERALA
682301
India |
| Phone |
7907112674 |
| Fax |
|
| Email |
drbindhuprasanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Ayurveda College and Hospital, tripunithura, Eranakulam District, kerala state, India , 682301 |
|
|
Primary Sponsor
|
| Name |
Goverment ayurveda college Tripunithura |
| Address |
Department of kayachikitsa
Govt ayurveda college
Tripunithura P O, Eranakulam District, Kerala state, India, 682301 |
| Type of Sponsor |
Government 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 Sumy C R |
Govt ayurveda college and hospital |
OP Number 1, Department of kayachikitsa
Eranakulam dist
Kerala state
Department of kayachikitsa
Govt ayurveda college
Tripunithura
Eranakulam dist
Kerala state
Ernakulam
KERALA |
09995906068
sumyshijuraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH Govt ayurveda college Tripunithura Kochi Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pachanamrutham kashayam, Reference: Sahasrayogam jwaradhikaram, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: along with shaddharanam tab(2) Medicine Name: Shaddharanam tablet, Reference: Susrutha samhitha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Pachanamrutham kashayam), Additional Information: along with Pachanamrutham kashayam(3) Medicine Name: Dadimadi grutham, Reference: Astanga hrudayam pandu roga chikitsa adikara, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -hot water), Additional Information: It is taking after 7 days course of deepana pachana medicines ( pachanamrutham ks & shaddharanam tab |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects within the age group of 18 years to 60 years
Subjects having primary hypothyroidism
Subjects who is willing to participate
Subjects who are eligible for snehapana |
|
| ExclusionCriteria |
| Details |
Subjects who are on conventional medicines on hypothyroidism
Subjects who are having uncontrolled systemic illness existing together with hypothyroidism
Pregnant and lactating mother
Subjects with TSH value more than 25 IU/ml
Subjects with total cholesterol above 300 mg/dl
Subjects who undergone thyroidectomy surgery
Subjects with hereditary defects on hormone synthesis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 32 |
97 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in value of Free T4
Change in value of TPO -Ab Titre
Assessment of Zulewskis clinical score
Nottingham quality of life assessment
|
0th and 98th day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Primary Hypothyroidism is an emerging health issue in India and worldwide 42 million people in India are suffering from Thyroid disease Thyroid abnormalities are diagnosed based on laboratory test results like Free thyroxine and thyroid stimulating hormone TSH Anti TPO Anti thyroglobulin Constant use of conventional hormonal therapy is able to normalyse the laboratorial parameters of hypothyroidism But many of the symptoms persists and quality of the life of the affected has not been improved much So any intervention which reduce the severity of signs and symptoms of the disease will be highly beneficial to the society In Ayurvedic point of view the medicines are giving to activate digestive fire and fresh up the gut microbiota so the metabolism will be corrected and the thyroid gland also will start to function normally and patient will recover from hypothyroidism permanently The study design is interventional pre and post test with a sample size of 34 subjects fulfilling the inclusion and exclusion criteria Data collection will be done by doing blood investigations and clinical observations case proforma zulewski clinical score for hypothyroidism and Nottingham quality of life assessment Pachanamrutham kashayam 48 ml along with 2 shaddharanam tab morning and evening one hour before food shall be given to participants for 7 days From 8th day onwards 10 ml dadimadi ghrutham at bed time along with hot water shall be given for 90 days Data collected will be statistically analysed through appropriate tests and conclusions will be drawn |