FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/06/034158 [Registered on: 10/06/2021] Trial Registered Prospectively
Last Modified On: 19/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To develop a unani medicine for the treatment of subclinical hypothyroidism 
Scientific Title of Study   A Clinical Study On Subclinical Hypothyroidism and its Management with An Extract of Jawarish e Bisbasa Formulation- A Randomized Double-Blind Placebo Controlled Clinical Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Irshad 
Designation  MD student 
Affiliation  Ayurvedic and unani tibbia college hospital 
Address  Opd no 4, department of moalijat, ayurvedic and unani tibbia college hospital ajmal khan road karol bagh

Central
DELHI
110005
India 
Phone  7011724763  
Fax    
Email  Irshadfaiz23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rais Ur Rahman 
Designation  Professor and supervisor 
Affiliation  Ayurvedic and Unani Tibbia College Hospital 
Address  Opd no 4, department of moalijat, Ayurvedic and unani tibbia college hospital ajmal khan road karol bagh

Central
DELHI
110005
India 
Phone  9313980776  
Fax    
Email  drrahman002@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rais Ur Rahman 
Designation  Professor and supervisor 
Affiliation  Ayurvedic and Unani Tibbia College Hospital 
Address  Opd no 4, department of moalijat, Ayurvedic and unani tibbia college hospital ajmal khan road karol bagh

Central
DELHI
110005
India 
Phone  9313980776  
Fax    
Email  drrahman002@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and unani tibbia college hospital ajmal khan road karol bagh delhi 110005 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and unani tibbia college hospital ajmal khan road karol bagh delhi 110005 
Type of Sponsor  Government medical college 
 
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 Irshad  Ayurvedic and unani Tibbia college and Hospital  Department of Moalijat, Ayurvedic and unani Tibbia college Hospital, Ajmal Khan Road, Karol Bagh
Central
DELHI 		 7011724763

Irshadfaiz23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvedic and unani Tibbia college Hospital Institutional Ethics Committee  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. Ayurveda Condition: DHATUVAISHAMYAM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  50% Hydro alcoholic Extract of jawarish e bisbasa formulation filled in 1 capsule (500mg) twice a day orally  50% Hydro alcoholic Extract form of bisbasa(Myristica fragrans), zanzabeel(Zingiber officinalis), Asarun(Valeriana wallichii), Taj qalmi(Cinnamomum tamala) Darchini(Cinnamomum zeylanicum), Filfil siyah(Piper nigrum), Qaranfal(Szygium aromaticum), Filfil daraz(Elettaria cardamomum), Heel kalan(Ammomum subulatum)  
Comparator Agent  Placebo capsule 500 mg twice a day orally  Corn flour  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed cases of subclinical hypothyroidism, patients willing to participate and sign the understood and informed consent form 
 
ExclusionCriteria 
Details  Pregnant and lactating women, renal and hepatic sufficiency, malignancy, patient unwilling to sign the informed consent form, patient taking hormonal therapy 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
TSH, cold intolerance, tiredness, constipation will be assessed  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess lipid profile  6 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/07/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Diagnosed cases of subclinical hypothyroidism who fulfill the inclusion criteria, will be enrolled in the study after making them understand about the study and taking their informed written consent. Patients will be allocated into two groups, 20 in test group & in control group respectively by using "block randomization" method. Test group will be subjected to 1 capsule (500 mg each) of extract of jawarish e bisbasa formulation twice a day orally. Blinding would be done by the pharmacist and distribution of drug will be as per the block randomization method. Patients would be followed up on 7th, 15th, 30th and 42nd day and clinically evaluated on assessment parameters. The data for both the groups will be statistically analyzed and compared with each other using appropriate statistical tests. The safety of the test drug will be ensured by monitoring the Haemogram with ESR and serological indicators for kidney and liver. Any unwanted effect of the drug during study will be noticed carefully.  
Close