Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
None listed
Sponsors
Ayurveda House Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: -Adult male or female participants aged eighteen to thirty five years at the time of enrollment. Participants will be categorized into Group A consisting of participants aged eighteen to twenty five years, which will be approximately eighty percent of the total sample, and Group B consisting of participants aged twenty six to thirty five years, which will be approximately twenty percent of the total sample. -Participants with a body mass index below twenty kilograms per square meter. -Participants with poor appetite, confirmed by a Simplified Nutritional Appetite Questionnaire score of fourteen or below and a Council on Nutrition Appetite Questionnaire score of twenty eight or below. -Participants who perform routine physical activity or regular exercise. -Participants who are residing in urban or metropolitan areas. -Participants who are willing and able to provide written informed consent. -Participants who are willing to comply with all study procedures, including attending all scheduled visits and completing required questionnaires.
Exclusion criteria
Exclusion criteria: -Participants who have taken part in any other clinical trial within three months prior to enrollment. -Participants with a sedentary lifestyle or who are unable to perform routine physical activity. -Participants with known long term diseases that affect metabolism, including thyroid disorders, chronic digestive system diseases, conditions causing poor absorption of nutrients, or eating disorders. -Participants with a past or current history of tuberculosis, asthma, stomach ulcers, cancer, liver cirrhosis, hepatitis, or any other significant liver related disease. -Participants with heart related disorders or kidney related disorders, or any medical condition affecting the heart or kidneys. -Participants with a history of any major or minor surgery within one and a half years before screening. -Participants with any serious illness that requires frequent medical visits or continuous intensive medical treatment, as judged by the investigator. -Participants who have used weight gain supplements, appetite enhancing products, anabolic substances, or nutritional therapies meant for weight gain within thirty days before screening. -Participants with a history of uncontrolled or unstable diabetes. -Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. -Participants with known allergy or intolerance to any ingredient of i Gain Plus Tablet or Lets Gain Powder. -Participants with a history of drug abuse or alcohol dependence within five years before baseline. -Participants with any other condition which, in the opinion of the investigator, makes them unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Appetite 2. Change in Body Mass Index (BMI) 3.Change in Liver Function Parameters (LFTs)Timepoint: Day 0 - Visit 1 - (Baseline) Day 15 2 days - Visit 2 Day 30 2 days - Visit 3 Day 45 2 days - Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Anthropometric Measures 2.Quality of Life 3. Gastrointestinal Symptoms 4. Safety & TolerabilityTimepoint: Day 0 - Visit 1 - (Baseline) Day 15 2 days - Visit 2 Day 30 2 days - Visit 3 Day 45 2 days - Visit 4 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed