None listed
Conditions
Interventions
Intervention1: Himalaya ORSL: Route: Oral
Dose: 200 ml tetra pack per day for 7 Days
Intervention2: Himalaya ORSL: 1 pack per day 200ml tetra pack
(before/during/after moderate to vigorous physical ac
Sponsors
Himalaya Wellness Company (HWC)
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult subjects, both men and women within age group of 18 to 45 years. 2.Subjects willing to sign an informed consent document. 3.Subjects willing to adhere to protocol requirements throughout the study period. 4.Subjects who have not participated in any clinical study in the past 30 days. 5.Subjects who are willing to do moderate and vigorous physical activities at least 4 times a week as reported by the subjects. (Appendix I)
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant, nursing, or planning a pregnancy during study entry and through the duration of the study. 2.Subjects with known allergies to any of the ingredients of the test product. 3.Subject with clinically significant abnormal lab values detected at the time of screening as determined by the investigator. 4.Subject who had a history of hypersensitivity to any packaged rehydration beverage. 5.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder as determined by the investigator. 6.Subjects with clinically significant pre-existing systemic disease necessitating long-term medications as determined by the investigator. 7.Subjects not willing to refrain from taking any other similar supplements during the study period. 8.Subjects not willing to abstain from excessive intake of recreational products like tobacco/pan chewing, smoking, alcohol and any other as determined by the investigator during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety of HORS-051511 in healthy adults by the following assessments: 1.General Physical Examinations 2.Laboratory Examinations.Timepoint: 1 Day and 7 Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE): AEs/SAEs will be continuously monitored throughout the duration of the studyTimepoint: 7 Days | — |
Countries
India
Contacts
Public ContactMr Veeresh M Chakkadi
Himalaya Wellness Company
Outcome results
None listed