Benefits and harms of using moderately high dose Turmacin, an active ingrediant of turmeric on acute joint pain in healthy volunteers

Phase 1

Completed

• Registration Number: CTRI/2018/03/012367
• Lead Sponsor: atural Remedies Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-29
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1.All consenting adults aged between 18 and 65 years judged by Investigator to be in general good health on the basis of medical history

2.No knee joint discomfort/pain at rest;

3.Must achieve a knee joint discomfort/pain score of at least >= 40 mm on visual analogue scale (VAS) for pain after 10 minutes of brisk walk on the stepmill equipment.

Exclusion Criteria

1.Subjects having liver problems (raised ALT, AST), Heart (abnormal ECG / ECHO), kidney problems (raised creatinine), other muscle related problems (raised creatine kinase).

2.Subjects having neurological disorders

3.BMI greater than 32 kg/m2

4.Taking concomitant medication like pain relievers or complements/ multivitamin supplements/ phytotherapeutical products that interfere with the product or outcomes of the study.

5.Suffering from any kind of arthritic condition viz., autoimmune, infectious in the knee that could mislead the evaluation.

6.Having trauma or surgery histories that have affected the knee.

7.Having a disease that results in bad intestinal absorption

8.Women of child bearing age who do not wish to use approved birth control methods during study

9.Being pregnant or breastfeeding.

10.Allergic or hypersensitive to turmeric

11.Being participating or having participated in a clinical assay or intervention study within the previous 30 days before inclusion in the study

12.Being unable to follow the guidelines of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
joint pain on visual analogue scale after exerciseTimepoint: days 5 and 7

Secondary Outcome Measures

Name	Time	Method
adverse effectsTimepoint: days 5 and 7