Treatment of Hypertriglyceridemia with Fucus Vesiculosus vs Atorvastatin

Phase 3

Recruiting

• Conditions: Pure hyperglyceridemia,

• Registration Number: CTRI/2023/07/055898
• Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary

The study shall be a randomized comparative study in which patients will be recruited from the General OPD of the Institute/Unit. 

The principal analyses of primary and secondary outcomes will be carried out by using the "per protocol" approach. All statistical tests will be two-sided. All the data shall be assessed for normal distribution. All analyses will be conducted using IBM SPSS version 20.0. Kolmogorov-Smirnov tests shall be used to analyze the normality of the data distribution.Comparison of the baseline characteristics among the two treatment groups will be done using parametric and non-parametric tests like independent t test, Wilcoxon rank sum test.

The data should be presented n (%), Mean ±SD or median(IQR), odds ratio, relative risk. The result will be presented with 95% confidence intervals (Cl) and the p value<0.05 will be considered as the statistically significant. For the primary outcome and each of the secondary outcomes, per protocol analysis will be done.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-08
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Men and women aged 20-65 years.
• 2.Known case of Hypothyroid, Type 2 Diabetics and Hypertension with control under medication.
• 3.Other systemic disorders under control with treatment.
• 4.Women surgically sterile, post-menopausal, are agreed to practice adequate contraception.
• 5.Written Informed consent from the patient.
• 6.Cases falling under Mild and Moderate [20]category of Serum Triglyceride levels as per the classification of Endocrine Society 2010.

Exclusion Criteria

• 1.Pregnancy, breastfeeding.
• 2.Cases with other uncontrolled systemic diseases like Hypothyroidism, Cardiovascular, Endocrinal diseases or systemic infections.
• 3.Low levels of Vitamin D.
• 4.Previous history of cardiovascular disease and cerebra stroke.
• 5.Suffering from known liver disorders.
• 6.Cases falling under Severe category of Serum Triglycerides levels as per the classification of Endocrine Society 2010.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement assessment of the changes in Lipid profile at baseline, 8th week & 12th week	12 weeks

Secondary Outcome Measures

Name	Time	Method
BMI	FFQ

Trial Locations

Locations (1)

Regional Research Institute (Homoeopathy); 🇮🇳 Hyderabad, TELANGANA, India

Regional Research Institute (Homoeopathy)

🇮🇳Hyderabad, TELANGANA, India

Dr Hima Bindu Ponnam

Principal investigator

9490009899

drdewdrop@gmail.com