| CTRI Number |
CTRI/2025/02/081097 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Agnimukha churna and hamsapadadi vati in the management of subclinical hypothyroidism |
|
Scientific Title of Study
|
Efficacy of Agnimukha Churna and Hamsapadadi Vati in the Managememt of Subclinical Hypothyroidism-an open labelled randomized standard controlled clinical trail |
| 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 Sushmita Ninganure |
| Designation |
MD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jmanagar |
| Address |
Department of Kayachikitsa 4th floor Institute of Teaching and Research in Ayurveda(Institute of National Importance) Ministry of Ayush Government of India
Jamnagar-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9916806527 |
| Fax |
|
| Email |
sushmitan444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charmi S Mehta |
| Designation |
Lecture |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of kayachikitsa 4th floor institute building ITRA Jamnagar
GUJARAT
361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9428862264 |
| Fax |
|
| Email |
csmehta@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmita Ninganure |
| Designation |
MD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor Institute of Teaching and Research in Ayurveda(Institute of National Importance) Ministry of Ayush Government of India
Jamnagar-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9916806527 |
| Fax |
|
| Email |
sushmitan444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda (institute of national importance) ministry of Ayush
opposite city B division police station gurudwara road
jamnagar
gujarat
361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda Opposite City B division
Police station Gurudwara road Jamnagar
361008
Gujarat India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sushmita Ninganure |
PG hospital ITRA Jamnagar |
OPD No: 11 Department of
Kayachikitsa ITRA
Jamnagar, Opposite City B
division Police station,
Gurudwara road,
Jamnagar, 361008
Jamnagar
GUJARAT |
9916806527
sushmitan444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: AGNIVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Agnimukha churna, Reference: ajeerna rogadhikara, vangasena samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hamsapadadi vati, Reference: vaidyamanorama, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Thyroxine | tablet thyroxine 1.6mcg/kg body weight OD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged between 18-60 years of either gender.
2)Newly diagnosed or previously diagnosed patient of TSH level 4.32-10mlU/L.
3)Patients having no symptoms or few symptoms of subclinical hypothyroidism like tiredness, weakness, dry skin, cold intolerance, hair loss, constipation, weight gain with poor appetite, and menstrual abnormalities.
4)Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1)Serum TSH level more than 10mIU/L and less than 4.32mIU/L
2)Patient taking allopathic medication for subclinical hypothyroidism.
3)Patients suffering from any other systemic illness viz. with a known case of uncontrolled Diabetes (Random blood sugar more than 200mg/dl), uncontrolled Hypertension (systolic blood pressure more than 140mmHg or diastolic blood pressure more than 90 mmHg), Psychiatric disorders, cardiovascular events, cerebrovascular event, malignancy.
4)Patients suffering from secondary hypothyroidism, Hashimoto’s thyroiditis.
5)Pregnant and lactating patients.
6)Patients aged below 18 years and above 60 years of either sex.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the serum TSH level |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Improvement in symptoms of subclinical hypothyroidism.
b) Improvement in Agni
c) Improvement in the quality of life (Modified quality of life scale of thyroid)
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/05/2025 |
| 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="6"
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
|
The trial is a randomized standard controlled clinical trial to evaluate the role of Agnimikha churna and hamsapadadi vati in the management of Subclinical Hypothyroidism. A total of 30 patients will be enrolled in the study. Selected patients will be divided into 2 groups based on computer-generated randomization. In one group Agnimukha churna 6gm, twice a day will be given before lunch and dinner with lukewarm water. Hamsapadadi Vati 500mg 2 vati will be given after lunch and dinner for 60 days. In the second group levothyroxine tablet 1.6mcg/kg of body weight will be given empty stomach in the morning for 60 days. Followups will be carried out weekly for 1-month duration. The primary outcome of the study is a reduction in serum TSH levels. |