Clinical Study on â??Ortho21â?¿ of OnTop Vedics as a Pain Relief Oil.

Phase 3

Completed

• Conditions: Health Condition 1: M255- Pain in joint

• Registration Number: CTRI/2021/07/034690
• Lead Sponsor: OnTop Vedics A Division of OnTop Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-09-21
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

1. Adult subjects between the ages of 21 and 65 years (Both ages and all genders inclusive) with chronic pain attributed to arthritis and or acute pains such as sprains, muscle aches.

2. Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving joint pain, joint and muscle health.

3. Subjects who are willing to abstain from use of any topical ointment, cream etc that are indicated for mitigating pain and aches.

4. Subjects who have a pain score of 2-5 on a 10 point NRS at the time of screening in a minimum of one joint.

5. Subject who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.

6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion Criteria

1. Subjects with known hypersensitivity to the ingredients of the investigational product.

2. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.

3. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.

4. Subjects on remission from cancer of any type less than 5 years at the time of screening.

5. Subjects who are planning a pregnancy and - or currently breastfeeding.

6. Subjects who have participated in a clinical study less than 1 month before screening.

7. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc -, any medical condition that is unstable or poorly controlled or other factor -eg., planned relocation - that investigator felt would interfere with study evaluations and study participation.

8. Subjects who are unable to comprehend the responsibilities and adhere to the stipulations of the protocol.

9. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified