None listed
Conditions
Interventions
Intervention1: Dabur Honey: 1 table spoon (approx. 20 gm) Honey dissolved in one glass (Approx. 200 ml) of Lukewarm water in the morning on empty stomach for 90 days
Control Intervention1: Nil: Nil
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of Quality of life by The World Health Organization Quality of Life (WHOQOL-BREF) questionnaires. 2. Assessemnt of additional health related parameters including digestion, bowel movements, appetite, morning freshness. Timepoint: 0 days, 30 days, 60 days and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in body weight, BMI, waist circumference, waist to hip ratio, lipid profile, levels of physical fitness, Stamina and strength. 2. Assessment of immunity by number of episodes, severity and duration of illness occurred, 3. Assessment of overall effect on Health and Fitness as per the subject, overall product efficacy (PGA-E) & Safety (PGA-S) by physician. 4. Overall safety by assessing adverse events and clinically significant abnormal laboratories findings Timepoint: 0 days, 30 days, 60 days and 90 days | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Dabur India limited
Outcome results
None listed