STUDY OF SNEC30 (CURCUMA LONGA) CAPSULES (test drug) IN THE TREATMENT OF TYPE 2 DIABETES

Not Applicable

• Conditions: Health Condition 1: null- Type 2 Diabetes

• Registration Number: CTRI/2018/05/013775
• Lead Sponsor: Arbro Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Subject or his legally accepted representative is willing to give informed consent

2 Patients of either sex between the age group 18 to 65 years (both inclusive)

3 Suffering from diabetes type 2 ( between 1 to 10 years)

4 Patients with diabetes who administer oral hypoglycemic agents

5 Patients with HbA1c between 7.0-9.5 %.

Exclusion Criteria

1 Patients suffering from any of the following conditions will be excluded from the study:

a Type 1 diabetes mellitus

b Patients with severe hyperglycemia (FBS >234 mg% or PPBS > 360 mg%)

c Patients with fasting serum cholesterol >260mg% and serum Triglycerides >300 mg%.

d Patients with HbA1c more than 9.5 %.

e Patients with AST and ALT levels greater than

2 5 times the upper normal limits

f Severe renal, hepatic or respiratory disorder.

g Patients with psychiatric disorder.

h Patients with haematological disorders

I History of smoking (more than 10 cigarettes/day) or alcohol intake > 20 gm/day.

j Complications of diabetes such as;

Proliferative type retinopathy

Nephropathy with laboratory values greater than 1.5 times the upper normal limits

Presence of ketone bodies in urine analysis

Ischemic heart disease with any cardiac event in last 6 months

Fasting serum cholesterol >260mg. % and serum Triglycerides >300 mg%.

2 Patients with BMI >35 kg/m2

3 Patients who are likely to undergo surgery during the study period.

4 Patients who have participated in any investigational study in the last 4 weeks.

5 Patients having known hypersensitivity to the study drugs.

6 Patients with any severe infection

7 Patients with a history of intake of ANY Ayurveda/herbal/homeopathic/dietary supplements (including Vitamin E) or any alternative therapies in the last one month

9 Pregnant or lactating females and women in child bearing age refusing to use contraceptives.

Study & Design

• Study Type: PMS
• Study Design: Not specified