| CTRI Number |
CTRI/2020/03/023913 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to see the efficacy of Asgandh (Withania Somnifera) in Primary Hypothyroidism |
|
Scientific Title of Study
|
Evaluation of the add on effect of Asgandh (Withania somnifera) with Levothyroxine Sodium in Primary Hypothyroidism- A Randomized standard 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 |
Md Majid Hussain |
| Designation |
PG Scholar |
| Affiliation |
Luqman Unani Medical College Hospital and Research Center |
| Address |
PG dept. of Moalajat, Luqman Unani Medical College Hospital and Research Centre,
12 Naubag
Bijapur
KARNATAKA
586101
India |
| Phone |
8282929092 |
| Fax |
|
| Email |
drmajid8282@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Qudrathullah |
| Designation |
Professor and HoD Moalajat |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
PG dept. of Moalajat, Luqman Unani Medical College Hospital and Research Centre, 12 Naubag
Bijapur
KARNATAKA
586101
India |
| Phone |
|
| Fax |
|
| Email |
drqudtathullah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Khalid |
| Designation |
Assistant professor |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Luqman Unani Medical College Hospital and Research Centre
12 Naubag
Bijapur
KARNATAKA
586101
India |
| Phone |
|
| Fax |
|
| Email |
khalidhameedkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Medical College, Hospital & Research Centre, Bijapur, Karnataka |
|
|
Primary Sponsor
|
| Name |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
12,Naubag Bijapur Pin 586101 Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 Majid Hussain |
Luqman Unani Medical College, Hospital & Research Centre |
Moalajat OPD-1, Ground Floor, dept. of Moalajat, LUMC, 12, Naubag Bijapur, Karnataka
Bijapur
KARNATAKA |
8282929092
drmajid8282@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of LUMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asgandh (Withania somnifera) |
Drug dosage: Safoof Asgandh: 1 gm twice a day
Form: Capsule
Route of administration: Orally
Duration of therapy: 60 days |
| Comparator Agent |
Levothyroxine sodium |
Levothyroxine sodium: 50mcg
Form: Tablet
Route of administration: Oral
Duration of therapy: 60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinically diagnosed and know cases of primary hypothyroidism with or without treatment.
2 Patients having TSH level range between 10-20 mu/I.
3 Patients who are willing to give consent.
|
|
| ExclusionCriteria |
| Details |
1 Subjects with clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic disorder
2 Hyperthyroidism
3 Pregnant and lactating mothers
4 Patients who fail to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in objective parameters |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fatigue
Cold intolerance
Constipation
Weight gain |
Before treatment, 15th day, 30th day, 45th day, after treatment |
|
|
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 3 |
|
Date of First Enrollment (India)
|
16/03/2020 |
| 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)?
|
|
Brief Summary
|
Enrolled cases of primary hypothyroidism after obtaining a written informed consent will be randomly allocated into 2 groups, viz; Group A and Group B, 20 subjects in each group. The Group-A subjects will be given Asgandh in dose of 1gm twice a day in empty stomach with normal water plus Levothyroxine sodium with dosage of 50mcg once a day in empty stomach with normal water. Group-B subjects will be given Levothyroxine sodium 50mcg once a day in empty stomach with normal water for 60 days. All the patients will be assessed for subjective symptoms fortnightly and Thyroid profile Level before and after the treatment. The data for both the groups will be statistically analysed and compared with each other using appropriate statistical tests. The significance difference of p <0.05 will be taken into consideration for efficacy outcome. |