| CTRI Number |
CTRI/2018/05/013864 [Registered on: 14/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Hyperlipedemia with Unani formulation |
|
Scientific Title of Study
|
Clinical trial on Hyperlipidemia (Kasrat-e-Shahmuddam) with UNIM-763 |
| Trial Acronym |
KSD/HL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSD/HL/CRIUM/2008 version: 01 dated 9/4/08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Kareemullah |
| Designation |
Research Officer (Unani) |
| Affiliation |
Central Research Institute of Unani Medicine |
| Address |
ROPD, R.No.3, CRIUM,
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda
ROPD, R.No.3,
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
9177376011 |
| Fax |
|
| Email |
kareemullah1757@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munawwar Hussain Kazmi |
| Designation |
Director I/c |
| Affiliation |
Central Research Institute of Unani Medicine |
| Address |
ROPD, Room no. 3, CRIUM,
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
9030168455 |
| Fax |
|
| Email |
drmunawwar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahmed Minhajuddin |
| Designation |
Research Officer (Unani) |
| Affiliation |
Central Research Institute of Unani Medicine |
| Address |
ROPD, Room no. 3, CRIUM,
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
9177376011 |
| Fax |
|
| Email |
ahmedminhajuddin@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DG, CCRUM, Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
61-65, Institutional Area Opp. D-Block, Janakpuri New Delhi – 110 058
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minhajuddin |
Central Research Institute of Unani Medicine |
Room no. 3, ROPD, 8-3-168/A/1/UM, AGs Colony Road, erragadda
Hyderabad
ANDHRA PRADESH |
9177376011
ahmedminhajuddin@yahoo.com |
| Dr S Kareemullah |
Central Research Institute of Unani Medicine |
Room no - 3, ROPD, 8-3-168/A/1/UM, A.Gs Colony Road,
Hyderabad
ANDHRA PRADESH |
9177376011
kareemullah1757@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| CCRUM Headquarters |
Approved |
| Some Changes done by IEC, CRIUM, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, Hyperlipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIl |
Nil |
| Intervention |
UNIM-763: 2 capsule of 500 mg each twice a day after meals |
2 capsule of UNIM 763, 500 mg each given twice a day after meals |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Serum cholesterol : > 200 mg/dl
2. Serum Triglycerides : >150 mg / dl
3. LDL : > 115 mg/ dl
4. HDL : > 40
5. Patient should be willing to cooperate the study protocol
6. Patient should be give written informed consent
7. Patient should not have any other disease.
|
|
| ExclusionCriteria |
| Details |
1. Un control diabetes mellitus
2. History of IHD
3. History of drug/alcohol abuse
4. Non cooperative patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Serum Cholesterol and Serum Triglycerides |
Baseline, 1st month, 2nd month, 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety with Pathological and biochemical tests |
Before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2008 |
| Date of Study Completion (India) |
31/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="9"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hyperlipidemia is an increase in either plasma cholesterol, plasma triglycerides. Epidemiological study indicate that cholesterol level above 250 mg/100 ml. significantly raise the risk for coronary heart disease *CHD). Recent clinical trials show that treatment of hyperlipidemia with allopathic drugs reduces the risk for coronary heart disease. Some of the Unani drugs have the capacity to regulate lipid abnormalities. If atherosclerosis can be prevented by regulating the abnormal lipid metabolism, we may be able to manage successfully one aspect of coronary heart disease. |