| 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
|
|
|
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
|
|
|
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. |