None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company (HWC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult male or females aged between 18 to less than 45 years with normal body mass index (BMI) 18.5-24.9 kg/m2. 2. Healthy adults as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests (as specified in Appendix1). 3. Healthy adults who refrain from taking any oral/ topical medication at least 15 days prior and during the study period. (SOS medications to be allowed during the study for any specific medical condition like paracetamol for fever). 4. Healthy adults who have not participated in any other similar clinical study within the last 3 months of screening. 5. Healthy adults who willingly sign the informed consent and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1. Patients with known clinically significant cardiovascular, respiratory,cerebrovascular, hepatic, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the Investigator. (Patients with any chronic medical condition under control to be also excluded). 2. Patients with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score (Appendix 2) more than 1 for any one of the 15 questions to be excluded). 3. Patients with history of significant renal disease or urinary symptoms; past history of urinary stones, or history of any previous urogenital invasive procedures. 4. Patients with known history or present condition of allergic response to any of the ingredients in the investigational product. 5. Patients with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications. 6. Patients with any current infections (bacterial, fungal, viral) at the time of screening as determined by the investigator. 7. Adults who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study. 8. Pregnant as assessed by UPT & history of amenorrhea and lactating women. 9. Women of child-bearing potential who are refusing to use adequate contraception throughout the study period. 10. Males who are refusing to use adequate contraception throughout the study period and refusing from donating sperm from first admission to the study until 90 days after the study completion. 11. Known alcohol, any other substance abuse or any other reason (physical, psychological, or social) that can interfere with the participant s compliance to the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events during the study period. 2. Proportion of participants withdrawing from trial because of adverse events (tolerability). 3. Gastrointestinal (GI) tolerability during the study period.Timepoint: Day 0, Day 1 and Day 7+1 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan
Himalaya wellness Company (HWC)
Outcome results
None listed