None listed
Conditions
Interventions
Intervention1: CL18100F4: 500 mg, One capsule daily in the night after dinner for 21 Days
Control Intervention1: NA: NA
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects aged between 25- 55 years with a Body Mass Index (BMI) of 25 to 39.9 kg/m2. 2.Subjects have been taking oral semaglutide for greater than or equal to 3 months and experiencing gastrointestinal symptoms. 3.Subjects with FBG less than 125 mg/dL. 4.Subjects willing to abstain from taking prokinetic agents or other drugs known to affect gastric motility such as narcotic analgesics, antacids and proton pump inhibitors etc. 5.Subjects agree not to discontinue or switch from GLP-1 receptor agonist treatment. 6.Subjects with normal thyroid profile. 7.Female subjects of childbearing potential must be using a medically acceptable form of birth control.Post-menopausal subjects must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 8.Subjects willing to comply with all the study related assessments and activities. 9.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent. 10.Subjects considered generally fit for the study by the investigator as per health history and routine clinical investigations during screening.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant, lactating or planning to become pregnant during the study duration. 2.Subjects with medical history of dizziness, fainting or vasovagal attacks. 3.Subjects with no gastrointestinal symptoms in last 2 weeks. 4.Subjects with a known allergy or sensitivity to herbs or spices or plant products in general and or allergic to botanical ingredients contained in the study product. 5.Subjects with a history or presence of gastrointestinal, hepatic or renal disease, or other conditions known to interfere with the distribution, metabolism or excretion of drugs. 6.Subjects with any disease or abnormalities related to gastrointestinal tract, pancreatic, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, neurologic diseases, and malignancies. 7.Expectation of any surgery during the study period. 8.Subjects with HIV Positive status. 9.Subjects with uncontrolled hypertension and diabetes. 10.Subjects consuming alcohol or smokers. 11.Subjects who regularly consume more than 3 cups of coffee or the equivalent in energy drinks. 12.Subjects with history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 13.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures. 14.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period: Gastrointestinal symptom (GIS) questionnaireTimepoint: Day 1, Day 7 and Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period: Constipation assessment scale (CAS)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Complete spontaneous bowel movement (CSBM) (No. of bowel movements per week)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Gastro Esophageal Reflux Disease Health Related Quality of Life scale (GERD-HRQL)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Perceived stress scale (PSS-10)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Athens insomnia scale (AIS)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Digestion-associated Quality of Life Questionnaire (DQLQ)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Rescue medicationTimepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Victoria Bowel Performance Scale (BPS)Timepoint: Day 1, Day 7 and Day 21;Change from baseline to end of the study period: Daily record of gastrointestinal symptoms (Nausea, vomiting, diarrhoea, & constipation).Timepoint: Day 1, Day 7 and Day 21 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed