FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/011962 [Registered on: 19/02/2018] Trial Registered Prospectively
Last Modified On: 04/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Majoon-e-Sarakhs in Primary Hypothyroidism 
Scientific Title of Study   Evaluation of the add on effect of Majoon-e-Sarakhs with levothyroxine in Primary Hypothyroidism  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MD ANZAR ALAM 
Designation  PhD Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore-560091
Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore 560091
Bangalore
KARNATAKA
560091
India 
Phone  9916164662  
Fax    
Email  dranzarnium@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Aleemuddin Quamri 
Designation  Reader 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore 560091
Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore 560091
Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Aleemuddin Quamri 
Designation  Reader 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore 560091
Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore 560091
Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Dept of Moalajat National Institute of Unani Medicine, Kottigepalya, Magdi Main Road Bangalore 
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 
MD ANZAR ALAM  National |Institute of Unani Medicine  Dept of Moalajat, National |Institute of Unani Medicine (NIUM) Bangalore
Bangalore
KARNATAKA 
9916164662

dranzarnium@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diagnosed cases of Primary Hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  levothyroxine  Oral Route: 1.6 μg/kg Body Weight /day 
Intervention  Majoon-e-Sarakhs and levothyroxine   Oral Route: Dose: 10 gm twice a day Oral Route: 1.6 μg/kg Body weight /day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Diagnosed patients of Qillat-e-Ifraz-e-
Darqiyya Ibtidai
2. TSH >5 and <15µIU/ml
3. Patient of both sexes.
4. Patient in age group of 18 to 45 years.
5. Patients able to participate in the study and ready to follow the instructions and sign the consent form.
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating mothers.
2. TSH <5 and >15µIU/ml
3. Patients below 18 and above 45 years
4. Complicated cases of hypothyroidism.
5. Known cases of metabolic and systemic diseases
6. Hyperthyroidism.
7. Patients who fail to give consent.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Decreased level of TSH  Follow Up: 0th , 30th , 45th and 60th day  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Subjective parameters  60 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/02/2018 
Date of Study Completion (India) 25/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/06/2019 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
After approval of thesis, I will send for publication in National/International Indexed Journal 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The present study was carried out as a randomised standard control adjuvant clinical trial, to evaluate the, add on effect of Majoon-e-Sarakhs with Levothyroxine in Primary Hypothyroidism (Qillat-e-Ifraz-e-Darqiyya Ibtidai). There was no statistically significant difference in baseline characteristics of patients in test versus control group. Samples are matched with age and gender (p=0.110). In this study prevalence of hypothyroidism; females: males are 19:1. The study effects on primary outcomes (TSH, FT3, FT4) and secondary outcome (weight gain, hair fall, cold intolerance, lethargy, constipation) were found significantly reduced in both groups (p<0.001). The results were assessed statistically using two tailed student t test, paired proportion test and Fischer exact test, Kruskall-Wallis with post Dunn’s multiple comparisons tests for intergroup comparisons,. Safety parameters assessment showed that they remained in the normal range in both the groups throughout the treatment. There is no any adverse event or reaction observed or reported during the study either in adjuvant or control group. The study was conducted on 100 patients, which might limit the generalisations of the inferences; however it still suggests the effective role of Majoon-e-Sarakhs in hypothyroidism. Further research is needed in large sample, multiple groups, multiple centres, and special population groups of elderly, children and pregnant women, etc. to bring up this simple Unani compound formulation into the domain of rigorous evidence based medicine.

 
Close