Clinical study to evaluate efficacy and safety in health & immunity related parameters of Dabur Ratnaprash formulation

Phase 2/3

Completed

• Conditions: Immunity and Health related parameters

• Registration Number: CTRI/2014/07/004804
• Lead Sponsor: Dabur India Ltd

Brief Summary

The study will be a multicentre, randomized, open label, parallel-group study which is intended to evaluate the safety and efficacy of Dabur Ratnaprash in health and immunity parameters. Healthy subjects in the age group of 18-60 years will be randomized to either of the two groups i.e. Ratnaprash followed by milk and only milk group twice daily in 1:1 ratio.Theglass of milk may be between 100-200 ml. Treatment period will be of 90 days with total visit of 5 visits including screening. Total completers for the study is planned to be 100 subjects. The following parameters will be evaluated like Physical examination, Vital signs, Assessment of level of Energy and overall health status, physical fitness, level of endurance or stamina and physical strength, level of stress, Physician’s Global evaluation, Laboratory parameters for safety and immunity and Palatability etc at various intervals of time.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-08
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Male and female subjects aged 18 to 60 years (both the ages inclusive) •Ready to provide written informed consent •No history of any known allergy with Chyawanprash like products or any of the ingredientts of the Ratnaprash •Willing to come for the follow up visits for evaluation.

Exclusion Criteria

• •Presence of clinically significant abnormal laboratory, ECG or X-ray findings during screening.
• •Patients with known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI) •Patients participated in another clinical drug trial within 3 months before recruitment in this trial •Any other medical condition that in the Investigators opinion would preclude patient participation •Pregnant and breast feeding women and women of child bearing age refusing to use contraceptive measures •Immunologically compromised individuals.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of quality of life (QoL) and number of episodes, severity and duration of illness during the study period	90 days (3 months)

Secondary Outcome Measures

Name	Time	Method
To assess level of Energy and overall health status, physical fitness, level of endurance or stamina and physical strength, level of stress, Physician’s Global evaluation, Laboratory parameters for safety and immunity and Palatability	90 days (3 months)

Trial Locations

Locations (3)

Ayurveda Research Center; 🇮🇳 Nashik, MAHARASHTRA, India

PDEAs College of Ayurveda and Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Shree Gurudeo Ayurved College; 🇮🇳 Amravati, MAHARASHTRA, India

Ayurveda Research Center

🇮🇳Nashik, MAHARASHTRA, India

Dr Shishir P Pande

Principal investigator

9420830818

shishir.nsk@gmail.com