| CTRI Number |
CTRI/2026/01/100604 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Unani Medicine (Arjun Chal) in Dyslipidemia |
|
Scientific Title of Study
|
Efficacy of Arjun Chal in Dyslipidemia: A Randomized Controlled Study |
| 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 Ansari Ambareen Ansari Mohammad Javeed |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka |
| Address |
National Institute of Unani Medicine Kottegepalya
Magadi Main Road
Bangalore
KARNATAKA
560091
India |
| Phone |
9146017601 |
| Fax |
|
| Email |
ambareenansari1024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Associate Professor and HoD Department of Moalajat |
| Affiliation |
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka |
| Address |
National Institute of Unani Medicine Kottegepalya
Magadi Main Road
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Associate professor and HoD Department of Moalajat |
| Affiliation |
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore Karnataka |
| Address |
National Institute of Unani Medicine Kottegepalya
Magadi Main Road
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Bangalore |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottegepalya
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 |
| Dr Ansari Ambareen Ansari Mohammad Javeed |
National Institute of Unani Medicine,Banglore |
Department of Moalajat OPD 1, OPD 2 and IPD of National Institute of Unani Medicine, Kottegepalya,
Magadi main road Bangalore Karnataka 560091
Bangalore
KARNATAKA |
9146017601
ambareenansari1024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) for Biomedical Research |
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 |
Arjun Chal (Terminalia arjuna) |
Fine Powder of Arjun Chal (3gm) will be given in capsule form daily in 2 divided doses. each capsule will contain 750mg of the Chal Arjun for 6 weeks. Patients will be advised to continue their routine statin treatment |
| Comparator Agent |
Placebo (roasted wheat flour) |
Placebo (roasted wheat flour) 3gm will be given in capsule form daily in 2 divided doses. each capsule will contain 750mg of the wheat flour for 6 weeks. Patients will be advised to continue their routine statin treatment |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient aged 20 to 70 years of either sex 2)Confirmed diagnosis of Dyslipidemia (as per NCEP ATP III guidelines)
Total cholesterol 200-250 mg per dL, or
LDL-C 130-189 mg per dL, or
HDL-C less than 40 mg per dL and more than 60 mg per dL, or
Triglycerides 150-499 mg per dL
3)Subjects on statins
4)Controlled Diabetes and Hypertension |
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women
2)Secondary causes of hyperlipidemia (example Hypothyroidism, nephrotic syndrome, uncontrolled diabetes)
3)History of Cardiovascular events (recent myocardial infarction, congenital heart disease or rheumatic heart disease, stroke, or unstable angina within the past 6 month)
4)Hepatic or renal failure or disease
5)Uncontrolled hypertension (SBP more than 160mmHg or DBP more than 100 mmHg) despite treatment
6)Poorly controlled diabetes (FBS more than 130mg per dL)
7)A medical condition that in the investigator opinion would interfere with treatment, safety or adherence to the protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in lipid profile (Serum Cholesterol, Serum triglycerides and LDL, VLDL, HDL). |
At baseline and after 6 weeks of clinical trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters (Dyspnea, Fatigue or Weakness, Chest pain, Palpitation)
Reduction in Systolic and Diastolic blood pressure. |
For 6 weeks (0,14th,28th,42nd) |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose: To Evaluate the Efficacy of Arjun Chal in Dyslipidemia Design: Double Blind Randomized Placebo Controlled Study Intervention: 44 diagnosed cases of dyslipidemia will be included in the study and randomly allocated into two equal groups. Written informed consent will be obtained from them. In the test group, Fine powder of Arjun Chal (3gm) will be given in capsule form daily in 2 divided doses; each capsule will contain 750mg of the test drug, for 6 weeks. Patients will be advised to continue their routine statin treatment. In the control group, a Placebo (roasted wheat flour) will be given in the same way as of the test group. Change in subjective parameters and blood pressure will be recorded on every follow-up. Changes in Lipid profile and liver enzymes will be recorded at baseline, and after 6 weeks of clinical trial. Both groups will be advised not to make any major changes in their dietary habits and physical activity during the clinical trial. Main Outcome Measures: Primary Outcomes: Changes in lipid profile (Serum Cholesterol, Serum triglycerides and LDL, VLDL, HDL). Secondary Outcomes: Improvement in subjective parameters (Dyspnea, Fatigue or weakness, Chest pain, Palpitation) Reduction in Systolic and Diastolic blood pressure. |