Clinical study on Honey in Healthy Volunteers

Not Applicable

Completed

• Registration Number: CTRI/2018/12/016613
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-09
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 113

Inclusion Criteria

1. Healthy human volunteers of either sex in age group of 18 to 60 years (both the ages inclusive)

2. Subjects willing to provide informed consent and ready to come for follow-up visits

Exclusion Criteria

1. Subjects with BMI greater or equal to 29

2. Presence of clinically significant abnormal laboratory, X-ray, ECG findings at screening.

3. History of drug addiction (less than one year)

4. Subjects suferring from Diabetes and Hypo or Hyper Thyroidism

5. Subjects with uncontrolled hypertension (HT) and known cases of Congestive heart failure (CHF), Unstable angina pectoris, Myocardial infarction (MI)

6. Pregnant and lactating mothers

7. Chronic Alcoholics/ Alcohol Abuse

8. Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV

9. Known hypersensitivity to any of the ingredients used in IP

10. Immunologically compromised individuals

11. Subjects participated in another clinical study within 3 months before recruitment.

12. Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigatorâ??s judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified