| CTRI Number |
CTRI/2011/06/001825 [Registered on: 22/06/2011] Trial Registered Retrospectively |
| Last Modified On: |
15/07/2011 |
| 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
|
clinical trial to study the comparative effect of a classical unani antiobesity drug safoof-e-muhazzil on hyperlipidemia in its classical powder form and in compressed tablet form |
|
Scientific Title of Study
|
CLINICAL STUDY ON HYPERLIPIDEMIA AND COMPARATIVE EVALUATION OF EFFICACY OF A COMPOUND UNANI FORMULATION (SAFOOF-E-MUAHAZZIL) AND COMPRESSED TABLET OF SAFOOF-E-MUHAZZIL IN ITS MANAGEMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrUmar jahangir |
| Designation |
MD scholar |
| Affiliation |
|
| Address |
MD Scholar
Department of moalejat(medicine),faculty of medicine
jamia hamdard
(Hamdard University)
South
DELHI
110062
India |
| Phone |
9891473381 |
| Fax |
|
| Email |
umar_jehangir@doctor.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAsim Ali Khan |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
department of moalejat(medicine),faculty of medicine
jamia hamdard
(Hamdard University)
South
DELHI
110062
India |
| Phone |
9811794448 |
| Fax |
|
| Email |
asim_jhamdard@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Drumar jahangir |
| Designation |
MD Scholar |
| Affiliation |
|
| Address |
MD Scholar,
Department of moalejat(medicine),faculty of medicine
jamia hamdard
(Hamdard UNiversity)
South
DELHI
110062
India |
| Phone |
9891473381 |
| Fax |
|
| Email |
umar_jehangir@doctor.com |
|
|
Source of Monetary or Material Support
|
| Majeedia Hospital and Faculty of Medicine,Jamia Hamdard (Hamdard University) |
|
|
Primary Sponsor
|
| Name |
Department of Moalejat Medicine Faculty of Medicine |
| Address |
Jamia Hamdard (Hamdard University),Hamdard Nagar, New Delhi-110062 |
| 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 |
| Drumar jahangir |
Room No-21, Majeedia Hospital |
jamia hamdard (Hamdard University),hamdard nagar, New Delhi-110062
South
DELHI |
9891473381
umar_jehangir@doctor.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,jamia hamdard |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hyperlipidemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compressed tablet of safoof muhazzil |
5tablets(equivalent to 5gms together) twice daily for six weeks
orally |
| Intervention |
safoof muhazzil |
5gms twice daily for six weeks
orally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Person aged 20 - 70 Years M/F
Patients willing to sign consent form & participate in Clinical Trial voluntarily.
Hyperlipidemic |
|
| ExclusionCriteria |
| Details |
Persons below 20 yrs and Above 70 yrs of age
Pregnancy
Liver diseases
Renal diseases
Diabetes mellitus Type II
Alcoholic
AIDS
Thyroid Disease
Drug intake ? Corticosteroids, Diuretics, Beta-blockers, Oral contraceptives, Cyclosporin, Androgens & Retinoids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hyperlipidemia |
0,2,4, and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| obesity, hypertension |
0,2,4, and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/05/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to evaluate the comparative effect of a compound Unani formulation (Safoof-e-Muhazzil) and compressed tablet of same drug i.e., Safoof-e-Muhazzil in hyperlipidemia against a standard control i.e, Atorvastatin and to establish their tolerability and efficacy. Serum cholesterol, VLDL, LDL, HDL, and Triglycerides together with BMI, Waist To Hip Ratio and Blood Pressure will be used to compare the status of Blood Lipids,obesity and Hypertension before and after treatment, and scored to determine the efficacy of the treatment. |