Skip to content

A Clinical Study to evaluate effectiveness of Unani Formulations in derangement of lipid profile

A Prospective, Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of Safoof-i Muhazzil and Arq-i Zeera in the Management of Dyslipidaemia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036193
Enrollment
60
Registered
2021-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified

Interventions

Intervention1: Group A: Study Group (Unani Drug): Safoof-i Mohazzil with Arq-i Zeera to be taken orally 3.5 gm BD and 75ml BD respectively for 8 weeks. Control Intervention1: Group B: Active Control G

Sponsors

National Research Institute of Unani Medicine for Skin Disorders
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (i). Participants of any gender aged 30 t0 60 years. (ii) Participants having any one or more of the following lipid abnormalities in blood: a. Total Cholestrol more than or equal to 200 mg/dl b. LDL Cholesterol more than or equal to 130 mg/dl c. HDL Cholesterol less than 40 mg/dl d. Serum Triglycerides 150-400 mg/dl (iii) Body Mass Index 23-40 kg/m2

Exclusion criteria

Exclusion criteria: i. Participants aged 60 years. ii. Serum Triglyceride 400 mg/dL iii. Body Mass Index (BMI) 40 kg/m2 iv. Participants having hypertension & diabetes v. Significant Pulmonary/ Cardiovascular/ Hepatorenal Dysfunction vi. Known cases of malignancy, HIV infection, AIDS, etc. vii. Any other clinical condition that in the opinion of the investigator would compromise the patientâ??s safety or successful participation in the trial. viii. Pregnancy and Lactation ix. Known allergy, sensitivity or intolerance to the study drug or any of its ingredients. x. Participants with active alcohol intake and/or drug abuse. xi. Participants not willing to sign the ICF and to attend treatment schedule regularly

Design outcomes

Primary

MeasureTime frame
Lipid Profile Timepoint: At baseline and end of trial

Secondary

MeasureTime frame
Haemogram Urine R/E & M/E LFTs RFTs ECGTimepoint: At baseline, 2nd week and end of trial

Countries

India

Contacts

Public ContactProf Qamar Uddin

National Research Institute of Unani Medicine for Skin Disorders

ccrumhqrsnd58@gmail.com8700027178

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026