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CTRI Number  CTRI/2022/05/042682 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 05/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Unani drug on thyroid disease 
Scientific Title of Study   Efficacy of Jadwar in Subclinical Hypothyroidism: A Randomized Single Blind Placebo Controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sayed Mohammed Saadudheen KP 
Designation  PG SCHOLAR 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Maolajat National Institute of Unani Medicine Kottigepalya Bengluru, India

Bangalore
KARNATAKA
560091
India 
Phone  9526737777  
Fax    
Email  saadbinsayyid@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mariyam Ahad 
Designation  Assistant Professor Department of Moalajat 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Maolajat National Institute of Unani Medicine Kottigepalya Bengluru, India
Delhi
Bangalore
KARNATAKA
560091
India 
Phone  9412456250  
Fax    
Email  dr.mariyamahad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mariyam Ahad 
Designation  Assistant Professor Department of Moalajat 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Maolajat National Institute of Unani Medicine Kottigepalya Bengluru, India
Delhi

KARNATAKA
560091
India 
Phone  9412456250  
Fax    
Email  dr.mariyamahad@gmail.com  
 
Source of Monetary or Material Support  
OPDs and IPDs NATIONAL INSTITUTE OF UNANI MEDICINE KOTTIGEPALYA BENGALURU 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF UNANI MEDICINE  
Address  National Institute of Unani Medicine Kottigepalya Bengaluru, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayed Mohammed Saadudheen KP  Department of Moalajat National Institute of Unani Medicine Hospital  Room no 1 & 2 Department of Moalajat National Institute of Unani Medicine Hospital
Bangalore
KARNATAKA 		 9526737777

saadbinsayyid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jadwar in the form of capsule  2gm/day for 56 days orally with water 
Comparator Agent  Placebo (starch) in the form of capsule  2gm/day for 56 days orally with water 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between 20-60 years of age of either gender.
Cases with TSH level between 5.5 and 15 mIU/L & Serum free thyroxine (fT4) level within normal range.
Ability to provide written informed consent and understand the risks and benefits of the protocol.
 
 
ExclusionCriteria 
Details  Pregnancy and lactation.
Complicated cases of Hypothyroidism, Diabetes, Liver Disorders, stroke, depression, or other neurologic/psychiatric disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in TSH level  56 days 
 
Secondary Outcome  
Outcome  TimePoints 
safety assessment like • AST, ALT
• KFT (Blood Urea Serum Creatinine)

 		 56 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 
Date of First Enrollment (India)   01/06/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Subjects will be screened clinically followed by laboratory investigation, whoever fulfilling the inclusion criteria will be enrolled into study after obtaining written informed consent, accordingly they will be randomly allocated into two groups, Test group and Control group (n = 15 each). The patients will be blinded for the study. Subjects in test group will be given Jadwar in capsule form 2gm/day in two divided doses, and the control group will be given identical dose of placebo. Both intervention used orally for the duration of 56 days. The study outcome will be assessed as the difference from the subjective and objective parameters measured at basline and 56th day.

The subjective parameters like Fatigue, Constipation and weight gain will assessed in each follow up on 14th day, whilst objective parameter TSH and fT4 will be assessed on baseline and end of the treatment.

 
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