Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: HPPE-092402: Gut microbes can metabolize herbal compounds and thereby increase their bioavailability and bioactivity, in addition to reducing their toxicity.
Ingredients
Flax seed, Gin
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female subjects between 18 to 45 years. 2. Subjects having mild to moderate Gastrointestinal symptoms like abdominal discomfort, bloating, gas, flatulence, abdominal fullness with GSRS score between 15 to 60. 3. Subjects who have not participated in any other similar clinical study within the last 3 months of screening. 4. Subjects willing to sign informed consent and follow the study procedure. 5.Women of child-bearing potential using reliable method of contraception and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy. 6. Male subjects willing to use adequate/ validated contraception and refrain from donating sperm from entering to the study until 90 days after the follow-up visit.
Exclusion criteria
Exclusion criteria: 1.Subjects with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, renal, congenital, immunological or any other disorder that can interfere with the study conduct and outcome in the opinion of the Investigator. 2.Subject has chronic health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator based on medical history and routine laboratory test results. 3.Subjects diagnosed with clinically significant GI disorders (Celiac, peptic ulcer, ulcerative colitis, Crohn disease, cancer). 4.Use of pre-and probiotics within 30 days prior to screening. 5.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product. 6.Pregnant and lactating women (as assessed by UPT u history of amenorrhea). 7.Known alcohol or any other substance abuse. 8.Any other reason (physical, psychological or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Efficacy Assessment of Gastrointestinal tolerability through GSRS (Gastrointestinal Symptoms Rating Scale). Timepoint: Day 1 & Day 7, Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety evaluation through Incidence of adverse events during the study period. 2.Proportion of subjects withdrawing from study because of adverse events (tolerability). Timepoint: Day 1 & Day 7, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed