A Clinical Study to evaluate the effectiveness of Jolly Tulsi 51 drops for Boosting Immune system and Detoxification in healthy subjects.
- Registration Number
- CTRI/2018/02/012126
- Lead Sponsor
- Jolly Health Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1.Healthy Male and female subjects who has taken at least 3 course any type antibiotics in the past 3 months.
2.Pregnant women will be included in the study.
3. Mentally, physically and legally eligible to give informed consent.
4. Male and female BMI between 18.0 â?? 30.0 kg/m2
5. Subjects is willing and able to comply with all trial requirements
6. Subjects who have not participated in a similar investigation in the past three months
7. Normal thyroid function
1. Subjects with history or presence of cancer
2. Subjects with history of a psychiatric disorder and or drug or alcohol abuse or dependency;
3. Subjects having a known intolerance to gluten or lactose
4. Subjects having a known allergy to any ingredient in the investigational product
5. Subjects with Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
6. Subjects having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of aerobic endurance and anaerobic performance by using ergometer from baseline to EOT <br/ ><br>2. Assessment of changes quality of life questionnaire from baseline to EOT <br/ ><br>Timepoint: Screening to End of Treatment
- Secondary Outcome Measures
Name Time Method 1. Incidence and Rate of adverse events. <br/ ><br>2. Changes in lab parameters ( Haematology and Liver function test) from baseline to EOT <br/ ><br>Timepoint: Screening to End of Treatment