An Open Label, Two Arm, Clinical Study to evaluate the Efficacy and Safety of powder as an Nutritional Supplement for tiredness and illness
- Registration Number
- CTRI/2019/09/021415
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Both male and female adult subjects between the age group of
2.More than 18 years to less than 60 years who are confirmed to have a history of work related fatigue as assessed through Fatigue assessment scale (FAS).
3.Both male and female adult subjects between the age group of More than 18 years to less than 60 years who are in post illness convalescence period.
4.Subject willing to refrain taking any other oral nutritional supplements during the study period.
5.Subjects willing to give written informed consent
Subjects who had not participated in similar kind of study in last 4 week.
1.Subject with clinically significant systemic illnesses treated with medication.
2.Subject with chronic illness which need immediate therapeutic intervention.
3.Subjects with chronic infectious condition treated with medications
4.Subjects who are hypersensitive to any of the ingredients,
5.Pregnant & lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall study compliance of the subject to the study medication <br/ ><br>Any adverse effects reported or observed during the study period <br/ ><br>Timepoint: The subject will be assessment visits are scheduled on day 1, day 30 days (telephonic) and at (End of Study) day 60 days. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Overall study compliance of the subject to the study medication <br/ ><br>Any adverse effects reported or observed during the study period <br/ ><br>Timepoint: The whole study duration is for 30 days with scheduled follow up visits at day 1, day 14, and day 30 day.