Health Condition 1: M255- Pain in joint
Conditions
Interventions
Intervention1: Isocure: Route of Administration : Oral
Formulation : Liquid
Dose : 1 sachet (35.71g) in 150ml cold water
Dosage : OD for 3 months
Control Intervention1: None: None
Sponsors
Essen Fooddies India Pvt Ltd
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subjects between the ages of 21 and 65 years (both ages and all genders inclusive) with active joint pain. 2. Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at improving joint pain, joint and muscle health. 3. Subjects who have a pain score of 2-5 on a 10 point VAS at the time of screening in a minimum of one joint. 4. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of the investigational product 2. Subjects who are on collagen supplements in any form. 3. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product. 4. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 5. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 6. Subjects on remission from cancer of any type less than 5 years at the time of screening 7. Subjects who are planning a pregnancy and/or currently breastfeeding. 8. Subjects who have participated in a clinical study less than 1 month before screening. 9. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 10. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 11. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. WOMAC Scale : Reduction of 20% from baseline 2. Pain Scale: Reduction of 20% from baseline 3. IP Feedback Questionnaire : Total Score of 20 Timepoint: 1. WOMAC Scale : Day 1, Day 45, Day 90 2. Pain Scale: Day 1, Day 45 Day 90 3. IP Feedback Questionnaire : Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed