None listed
Conditions
Interventions
Intervention1: Emothion: Dose: 200mg (100mg BID)
Dosage form: Capsule
Frequency: Twice a day after Breakfast and Dinner
Route of administration: Oral
Total Duration: 90 Days
Control Intervention1: Re
Sponsors
Gencor Pacific Organics India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female participants whose age is =18 and = 40 years. 2. Participants must provide a written and signed informed consent and comply with requirements of the study. 3. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol. 4. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement. 5. Female participant of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female participant of non-childbearing potential.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of skin allergy 2. Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour. 3. Patients undergoing treatment for any other systemic illness. 4. History of GERD, Chronic Diarrhea, Irritable bowel syndrome 5. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any investigational product or its excipients etc. 6. History of difficulty in swallowing. 7. Medication: Participants who have used the following substances within 1 week prior to screening (medication details required). 8. Pregnant, Lactating Women & women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study. 9. Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period. 10. Any other condition/reason which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Safety of subjects, vital signs will be recorded at each visit Mean Change in the Blood count, Lipid profile, Renal function and liver function test Skin health parameters - Pigmentation, Moisture & wrinkle using Mobile Skin Analysis System (Device), Skin analysis using- Dermatoscopy and Shade card score Change in dermatology Quality of life score. Timepoint: Day 0, Day 5, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDr Apoorva Raghavan
First Med Hospital Unit of Apollo Hospitals Enterprise Limited Chennai
Outcome results
None listed