Effect of Sil oil in Diabetes, hypertension and high Cholesterol levels.

Phase 2/3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus with circulatory complications,

• Registration Number: CTRI/2023/05/052246
• Lead Sponsor: SEIDECOSAA Division of M/s INDIAN SILK FIBRE CO, India

Brief Summary

- The subjects who fulfilled the inclusionand exclusion criteria will be enrolled in the study.

- 100 Participants will berandomized into 2 groups with 50 in each group.

- Arm 1 - Silk oil soft gel capsules + StandardTreatment for Diabetes, Hypertension and Hyperlipidemia: 50 study participants

- Arm 2 - Standard Treatment for Diabetes,Hypertension and Hyperlipidemia: 50 study participants

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-29
• Study Start: 2023-08-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subjects, aged 18 years and above.
• Subjects diagnosed with Diabetes with hypertension and hyperlipidaemia, (newly diagnosed and patients who are on treatment).

Exclusion Criteria

• 1.Subjects presenting with any other life threatening co morbid disease conditions like renal failure, liver failure or severe heart failure.
• 2.Participation in any other clinical study or test panel within the one month prior to entry into the study.
• 3.History of allergy to test product 4.History of HIV, HBV, Malignancy, alcohol or drug abuse.
• 5.Pregnant or lactating subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Polyphagia, Polyurea, Polydipsia, Fatigue, weight loss and Blur vision (if any)	4th 8th and 12th week
•Improvement of Systolic and Diastolic blood pressure	4th 8th and 12th week
•Improvement of Inflammatory markers like ESR and CRP.	4th 8th and 12th week
•Fasting blood glucose, Post prandial blood glucose and HbA1c levels	4th 8th and 12th week
•Lowering of LDL/VLDL/TG and increase in HDL	4th 8th and 12th week
•Number of Cardiovascular events (myocardial infarction/ stroke) during the study period.	4th 8th and 12th week

Secondary Outcome Measures

Name	Time	Method
•Patient and investigator feedbacks and Quality of Life will be assessed	•Adverse event monitoring (Laboratory data will be compared Pre and Post study to monitor for the safety of the subjects).

Trial Locations

Locations (1)

Mahathma Gandhi Medical College and Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Mahathma Gandhi Medical College and Research Institute

🇮🇳Pondicherry, PONDICHERRY, India

Dr Uma Narayanamurthy

Principal investigator

9842329417

numa.lally@gmail.com