| CTRI Number |
CTRI/2024/09/074424 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| 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 effect of Unani formulation in patient with Hyperlipidemia. |
|
Scientific Title of Study
|
An Open Labelled Randomised Controlled clinical study to evaluate the safety and efficacy of Qurs-e-Luk in cases of Fart-e-Tadassum fid-dam (Hyperlipidemia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Fareeha Kausar |
| Designation |
PG Scholar |
| Affiliation |
Govt. Nizamia Tibbi College and General hospital |
| Address |
OP No.122,PG Dept. of Moalijat Govt. Nizamia Tibbi college and general Hospital, charminar, Hyderabad, Telangana 500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9555851018 |
| Fax |
|
| Email |
fareehakausar677@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ahsan Faroqui |
| Designation |
HOD |
| Affiliation |
Govt. Nizamia Tibbi College and General hospital |
| Address |
OP No.122,PG Dept. of Moalijat Govt. Nizamia Tibbi college and general Hospital, charminar, Hyderabad, Telangana -500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9849139356 |
| Fax |
|
| Email |
dr.faroqui@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fareeha Kausar |
| Designation |
PG Scholar |
| Affiliation |
Govt. Nizamia Tibbi College and General hospital |
| Address |
OP No.122,PG Dept. of Moalijat Govt. Nizamia Tibbi college and general Hospital, charminar, Hyderabad, Telangana -500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9555851018 |
| Fax |
|
| Email |
fareehakausar677@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt.Nizamia tibbi college and general hospital Charminar Hyderabad Telangana 500002 India |
|
|
Primary Sponsor
|
| Name |
PG Dept. of Moalijat |
| Address |
OP No.122,PG Dept. of Moalijat Govt. Nizamia Tibbi college and general Hospital, charminar, Hyderabad, Telangana -500002 |
| 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 |
| Fareeha kausar |
Govt. Nizamia tibbi college and general hospital |
OP No.122,PG Dept. of Moalijat Govt. Nizamia Tibbi college and general Hospital, charminar, Hyderabad, Telangana -500002
Hyderabad
TELANGANA |
9555851018
fareehakausar677@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
QURS-E-LUK |
2.5gm-BD,with water, after meal, with 4 follow ups at interval of 15 days.
|
| Comparator Agent |
Tablet Atorvastatin-40 mg |
OD-with water after meal, with 4 follow ups at interval of 15 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of primary hyperlipidemia is selected for this clinical trial .
2.Patient with Serum Triglycerides (TG) more than 200-499 mg/dl , and Serum LDL Cholestrol more than 160-189 mg/dl, Serum Total Cholestrol more than 240 mg/dl,and VLDL less than30mg/dl. HDL Cholestrol up to 50 mg/dl included in this study.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant & Lactating women
2.Severe active coronary artery disease &
Ischemic Heart disease.
3. Uncontrolled DM
4.Alcoholism
5.Mentally retarded patients.
6.Patients with severe systemic disease & organ failure.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the abnormal elevated range of Triglycerides,serum LDL and VLDL cholesterol, serum total Cholesterol.and maintain normal HDL Cholesterol up to 50mg/dl. |
once in 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To maintain body weight, and reduce the risk factor of cardiovascular diseases. |
once in 2 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
05/10/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hyperlipidemia is one of the most important risk factor of Heart attack and stroke, it affects about 75-85% in the control population of comparable age. It impacts on patient health & social life which effect very badly. My aim to evaluate the therapeutic efficacy of formulated Unani drug and relief the nature of the disease. Management of Hyperlipidemia with sample size of 40 and 2 months treatment with some inclusion and exclusion criteria ( mentioned in part 6). The study has been planned. |