None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult male or female subjects aged between 18- 45 years. 2.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests (as specified in Appendix1). 3.Subjects 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.Subjects who have not participated in any other similar clinical study within the last 3 months of screening. 5.Women of child-bearing potential using reliable method of contraception within 2 months of screening and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy. 6.Subjects willing to sign informed consent and follow the study procedure.
Exclusion criteria
Exclusion criteria: 1.Subjects 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. (Subject with any chronic medical condition under control to be also excluded). 2.Subjects 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.Subjects with history of significant renal disease or urinary symptoms; past history of urinary stones, or history of any previous urogenital invasive procedures. 4.Subjects with known history or present condition of allergic response to the study product or any ingredients in the study product. 5.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications. 6.Pregnant and lactating women (as assessed by UPT & History of Amenorrhea). 7.Male subjects who is not willing to use adequate/ validated contraception and not willing to refrain from donating sperm from first admission to the study until 90 days after the follow-up visit 8.Known alcohol or any other substance abuse according to DSM-V criteria. 9. Any other reason (physical, psychological or social) that can interfere with the subject’s compliance with the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of safety of investigational product through general physical examination and laboratory investigations. 2.Incidence of adverse events during the study period. Timepoint: Day 1 & Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Gastrointestinal tolerability through Gastrointestinal symptom rating scale. 2.Proportion of subjects withdrawing from trial because of adverse events.Timepoint: Day 1 & Day 7 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed