| CTRI Number |
CTRI/2020/09/027924 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
23/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Unani drug on Dyslipidemia |
|
Scientific Title of Study
|
Efficacy of Arq-e-Biranjasif in Dyslipidemia – A Randomized Open labelled Standard Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIUM/IEC/2019-20/005/PhD/01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
FAROOQUI SHAZIA PARVEEN |
| Designation |
PhD scholar Department of Moalejat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept of Moalejat, National Institute of Unani Medicine, Kottigepalya
Dept of Moalejat, National Institute of Unani Medicine, kottigeplaya
Bangalore
KARNATAKA
560091
India |
| Phone |
8147438868 |
| Fax |
|
| Email |
shaziafarooquinium@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MOHD ALEEMUDDIN QUAMRI |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept of Moalejat, National institute of unani medicine
kottigeplaya
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
FAROOQUI SHAZIA PARVEEN |
| Designation |
PhD Scholar Department of Moalejat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept of Moalejat, National institute of unani medicine
kottigeplaya
Koppal
KARNATAKA
560091
India |
| Phone |
8147438868 |
| Fax |
|
| Email |
shaziafarooquinium@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Institute and Hospital,
Dept of Moalejat, OPD1/2, National Institute of Unani Medicine, Kottigepalya, Bangalore. |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepalya, Magadi main road, Bangalore, Karnataka, 560091 |
| 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 |
| Farooqui Shazia |
National Institute of Unani Medicine, Bangalore |
OPD 1/2, NIUM Hospital and research centre, National institute of unani medicine
kottigeplaya
Bangalore
KARNATAKA |
8147438868
shaziafarooquinium@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of NIUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arq Biranjasif |
Arq-e-Biranjasif 125ml once a day before meal orally for 8 weeks |
| Comparator Agent |
Tab.Atorvastatin |
Tab.Atorvastatin 10mg once a day orally for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Known cases of Dyslipidemia with disease history of < 3yrs with or without anti hyperlipidemic medication.
Total Cholesterol > 200- 239mg / dl27
Triglycerides < 499 mg / dl (High)
LDL >189 mg / dl27
HDL < 40 mg / dl in men and <50 woman27
VLDL >0.930–1.006 g/ L5
Ratio HDL to LDL < 6.3 in men and 5 in woman
Patients of both sex
Age: between 20-50 yrs
BMI ≤39.929
Known cases of DM type -2 with Dyslipidemia
Fasting blood sugar (FBS) > 126 mg/dl - < 150mg/dl30
Post Prandial blood sugar (PPBS) > 140 mg/dl - < 250mg/dl 5
Normotensives ( < 130 – 80 mm of Hg)
Patients who follow the protocol
|
|
| ExclusionCriteria |
| Details |
Known cases of Dyslipidemia, with disease history of > 3yrs
Total Cholesterol > 240 mg / dl
Triglycerides > 499 mg / dl (High)27
LDL < 189 mg / dl 31
HDL > 70 mg / dl
VLDL <0.930–1.006 g/L
Ratio LDL to HDL >6.3 in men and >5 in woman
Known cases of Type 2 Diabetes Mellitus with complications.
Fasting Blood Sugar >150 mg/dl32
Post Prandial blood sugar (PPBS) > 250mg/dl
Known cases of Hypertension 33Diabetes Mellitus type I, Hypothyroidism
Known cases on use of corticosteroids, and contraceptives.
History of cardiovascular, Renal, Liver diseases, AIDS and T.B.
History of alcoholism
BMI ≥ 40
Pregnant & lactating mothers
Age < 20 and > 50 years of age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Lipid profile |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/10/2020 |
| Date of Study Completion (India) |
08/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a open labelled, randomized, controlled, clinical trial comparing the safety and efficacy of arq biranjasif 125ml once a day before meal and tab Atorvastatin 10mg once a day for 8 weeks in 100 patients with dyslipidemic pateints will be conducted in Bangalore, Karnataka, India. The primary outcome measures will be Change in lipid profile level. |