Effect of Turmacin - an active component from Turmeric in improving joint health among healthy volunteers

Phase 2

Completed

• Registration Number: CTRI/2018/03/012359
• Lead Sponsor: atural Remedies Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

2.Having a disease that results in bad intestinal absorption

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

4.Being pregnant or breastfeeding.

5.Allergic or hypersensitive to turmeric

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

7.Being unable to follow the guidelines of the study

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

9.Subjects having neurological disorders

10.BMI greater than 32 kg/m2

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Joint pain reported on visual analogue scaleTimepoint: days 5,7,28,56,84

Secondary Outcome Measures

Name	Time	Method
Isokinetic strength assessed in different velocities in random orderTimepoint: Days 1 & 84;isometric and isokinetic knee extension for quadriceps and hamstrings at various angular velocity (60 degree/sec to 300 degree/sec)Timepoint: Days 1 & 84;Maximal isometric torque will be measured with knee extension from the knee flexed (90 degree) positionTimepoint: Days 1 & 84