| CTRI Number |
CTRI/2026/02/104059 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Jawarish Bisbasa and Jawarish Falafali in the patients of subclinical hypothyroidism. |
|
Scientific Title of Study
|
Clinical effect of jawarish bisbasa versus jawarish falafali in patients with subclinical hypothyroidism: A randomized comparative parallel clinical trial. |
| 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 Shaikh Sofia Tarannum |
| Designation |
PG Scholar |
| Affiliation |
Government Tibbi College and Hospital Kadam Kuan Patna |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital Kadam Kuan Patna
800003
Patna
BIHAR
800003
India |
| Phone |
8210079184 |
| Fax |
|
| Email |
sofiashaikhtarannum99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Najibur Rahman |
| Designation |
Associate Professsor and Head of Department, Moalajat |
| Affiliation |
Government Tibbi College and Hospital Kadam Kuan Patna |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital Kadam Kuan Patna
800003
Patna
BIHAR
800003
India |
| Phone |
7004484257 |
| Fax |
|
| Email |
drmdnajibur.rahman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Razi Ahmad |
| Designation |
Associate Professor, Moalajat |
| Affiliation |
Government Tibbi College and Hospital Kadam Kuan Patna |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital Kadam Kuan Patna
800003
Patna
BIHAR
800003
India |
| Phone |
7909035622 |
| Fax |
|
| Email |
dr.razi.ahmed91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Tibbi College and Hospital Kadam Kuan Patna
800003 |
|
|
Primary Sponsor
|
| Name |
Dr Shaikh Sofia Tarannum |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital Kadam Kuan Patna
800003 |
| 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 Shaikh Sofia Tarannum |
Government Tibbi College and Hospital Kadam Kuan Patna |
Medicine OPD number 38
Patna
BIHAR |
8210079184
sofiashaikhtarannum99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Government Tibbi College and Hospital Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jawarish Bisbasa |
Jawarish Bisbasa 5 g orally twice a day after meal with lukewarm water for 90 days. |
| Comparator Agent |
Jawarish Falafali |
Jawarish Falafali 5 g orally twice a day after meal with lukewarm water for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed subjects of subclinical hypothyroidism.
Subjects having TSH level more than 5.5 micro IU/ ml and less than 15 micro IU/ml.
|
|
| ExclusionCriteria |
| Details |
Subjects on iodine containing vitamins or minerals.
Subjects suffering with any chronic medical illness like DM, HTN, IHD, Heart Failure, CKD, RA etc.
Subjects with other than Subclinical Hypothyroidism, Myxoedema, Hashimoto’s thyroiditis, Riedel’s thyroiditis, Hyperthyroidism etc.
Subjects who fail to give consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in subjective parameters such as weight gain, cold intolerance, lethargy and constipation.
Reduction in TSH and complete thyroid profile before and after trial. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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="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
|
This study is an open label , randomized, parallel group trial for the evaluation and comparison of two unani compound formulations Jawarish bisbasa and Jawarish falafali in the management of subclinical hypothyroidism. Jawarish bisbasa is given orally 5 gram twice a day after meal with lukewarm water for 90 days in 30 patients. Jawarish falafali is also given 5 gram twice a day with lukewarm water for 90 days in 30 patients of comparative parallel group. The study will be conducted in Government Tibbi College and Hospital Kadam Kuan Patna Bihar. Primary outcomes will be reduction in subjective parameters such as weight gain, cold intolerance, lethargy and constipation. There will also be reduction in TSH level and complete thyroid profile before and after trial. |