None listed
Conditions
Interventions
Intervention1: Jolly Tulsi 51 drops: Dose: 5 drops daily for 56 days
oral
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Jolly Health Care
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of aerobic endurance and anaerobic performance by using ergometer from baseline to EOT 2. Assessment of changes quality of life questionnaire from baseline to EOT Timepoint: Screening to End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence and Rate of adverse events. 2. Changes in lab parameters ( Haematology and Liver function test) from baseline to EOT Timepoint: Screening to End of Treatment | — |
Countries
India
Contacts
Public ContactDr Harisha s
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed