A Healthy volunteer study on females and males for diabetic mellitus. ( Gymnema Sylvestre)

Not Applicable

Completed

• Registration Number: CTRI/2016/08/007221
• Lead Sponsor: GWELL CO LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-06-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1 Normal healthy human adult male and female volunteers between 18-45 years -both ages inclusive, of age, who have given written informed consent and are willing to participate in the study.

2 Volunteer having Body Mass Index of 18.5 to 24.9 Kg/m2 -Inclusive.

3 Volunteer with no evidence of underlying disease during the pre-study screening,medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study.

4 Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his participation in the study.

5 Volunteer having a 12 lead ECG recording within normal limits.

6 Volunteer with normal chest X-ray taken within 6 months before the day of dosing.

7 Volunteer will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.

Exclusion Criteria

1 Volunteer who is allergic to Gymnema Sylvestre or any component of the formulation and to any other related drug.

2 Volunteer with history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.

3 More specifically, volunteer with history or presence of significant:

History of chronic smoking -10 or more than 10 units per day of

cigarettes, bidis, or any other form- or chronic consumption of

tobacco products.

History of clinically relevant allergy -except for untreated,

asymptomatic, seasonal allergies at time of dosing- or any

allergic reactions to any drugs.

Asthma, urticaria or other allergic type reactions after taking any

medication.

Clinically significant illness within 4 weeks before the start of the

study.

Hypersensitivity to heparin.

4 History of Vascular collapse.

5 Volunteer who is scheduled for surgery within 7 days after study completion.

6 Volunteer who, through completion of any other clinical study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.

7 Volunteer who has taken prescription medication or over-the- counter products -including vitamins and products from natural origin- within 14 days prior to administration of IP, including topical medication meant for systemic absorption.

8 Volunteer who was hospitalized within 28 days prior to administration of the study medication.

9 Volunteer with history of difficulty in swallowing.

10 Volunteer who has unsuitable veins for repeated venipuncture.

11 Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study.

12 Volunteer who has:

Systolic blood pressure less than 90 mm of Hg or more than 150

mm of Hg Diastolic blood pressure less than 60 mm of Hg or more

than 94 mm of Hg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Fasting and post-prandial plasma glucose <br/ ><br>b) Adverse events, if any <br/ ><br>c) Abnormal hematology and biochemistry (basic panels) <br/ ><br>d) Abnormal vital signsTimepoint: Each group of 12 subjects (9 male and 3 female) will <br/ ><br>receive either active or placebo before a normal meal. Blood samples <br/ ><br>will be collected on Day 0 at Pre-dose (0.0 hrs), post dose -15 min, <br/ ><br>30, 45, 60 (1 hr), 90, 120 (2 hr), 4 hr, 6 hr. Each sample volume will <br/ ><br>not exceed 5 mLbiochemistry (basic panels) <br/ ><br>d) Abnormal vital signs

Secondary Outcome Measures

Name	Time	Method
Adverse events, if any <br/ ><br>Timepoint: Each group of 12 subjects (9 male and 3 female) will <br/ ><br>receive either active or placebo before a normal meal. Blood samples <br/ ><br>will be collected on Day 0 at Pre-dose (0.0 hrs), post dose -15 min, <br/ ><br>30, 45, 60 (1 hr), 90, 120 (2 hr), 4 hr, 6 hr. Each sample volume will <br/ ><br>not exceed 5 m