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CTRI Number  CTRI/2022/04/041632 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 01/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on primary hypothyroidism and its treatment with a Unani drug. 
Scientific Title of Study   A clinical study on the management of primary hypothyroidism with a unani polyherbal formulation-An open label single arm 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 Saema Khanam 
Designation  MD student 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Moalijat OPD no 04 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi

New Delhi
DELHI
110005
India 
Phone  9625973500  
Fax    
Email  drsaemakhanam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rais Ur Rahman 
Designation  Professor and Supervisor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Moalijat OPD no 04 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi

New Delhi
DELHI
110005
India 
Phone  9313980776  
Fax    
Email  drrahman002@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saema Khanam 
Designation  MD student 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Moalijat OPD no 04 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi

New Delhi
DELHI
110005
India 
Phone  9625973500  
Fax    
Email  drsaemakhanam@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New 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 Saema Khanam  Ayurvedic and Unani Tibbia College and Hospital  OPD no 4 Department of Moalijat Ajmal Khan Road Karol Bagh New Delhi 110005
New Delhi
DELHI 		 9625973500

drsaemakhanam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvedic and Unani Tibbia College and 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: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extract of Unani Polyherbal Formulation -Bisbasa (Myristica fragrans), Zanjbeel (Zingiber officinalis), Asarun (Asarum europaeum), Filfil Siyah (Piper nigrum), Qaranfal (Szygium aromaticum), Filfil Daraz (Piper longum), HeelKhurd (Elettaria cardamomum), Heel kalan (Amomum subulatum), Taj Qalmi (Cinnamomum tamala), Darchini (Cinnamomum zeylanicum),Asgandh (Withania somnifera), Muqil(Commiphora mukul), Kachnal (Bouhinia variegate)  2 capsules (500 mg each) twice a day orally for 6 weeks. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed cases of Primary Hypothyroidism with TSH level >20mIU/L. Patient willing to participate and sign the consent form. Patient willing to discontinue the drugs taking for the treatment of Primary Hypothyroidism. 
 
ExclusionCriteria 
Details  Patient unwilling to sign the consent form.
Patient taking hormonal therapy.
Pregnant and lactating women.
Renal and hepatic insufficiency and malignancy.
Patient with tachyarrhythmia.
Patient with increased bowel movements.
Patient with menorrhagia, metrorrhagia and polymenorrhea.
Patient with parkinsonism and tremors.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TSH, Free T3 & T4
Tiredness
Loss of appetite
Cold intolerance
Constipation
Sleep
will be assessed.
 		 6 Week 
 
Secondary Outcome  
Outcome  TimePoints 
Lipid Profile and Quality of Life will be assessed  6 Week 
 
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)   11/04/2022 
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 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 Primary Hypothyroidism, who fulfill the inclusion criteria, will be enrolled in the trial after making them understand about the study & taking their informed written consent. Patients will be given the test drug, prepared in the extract form of Unani Polyherbal formulation, 2 capsules (500 mg each) twice a day orally and would be followed up on 10th,20th, 30th and 42nd day and will be clinically evaluated on assessment parameters. The data will be statistically analyzed using appropriate statistical tests. The safety of the test drug will be ensured by monitoring the Hemogram and biochemical indicators for kidney and liver functions. Any adverse effects of the drug during study will be noticed carefully.

 

 
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