A Clinical Study to evaluate effectiveness of Unani Formulations in derangement of lipid profile
- Conditions
- Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified
- Registration Number
- CTRI/2021/09/036193
- Lead Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
(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
i. Participants aged <30 and >60 years.
ii. Serum Triglyceride <150 mg/dL or >400 mg/dL
iii. Body Mass Index (BMI) <23 or >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ipid Profile <br/ ><br>Timepoint: At baseline and end of trial <br/ ><br>
- Secondary Outcome Measures
Name Time Method Haemogram <br/ ><br>Urine R/E & M/E <br/ ><br>LFTs <br/ ><br>RFTs <br/ ><br>ECGTimepoint: At baseline, 2nd week and end of trial