| CTRI Number |
CTRI/2018/03/012359 [Registered on: 06/03/2018] Trial Registered Prospectively |
| Last Modified On: |
01/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Turmacin - an active component from Turmeric in improving joint health among healthy volunteers |
|
Scientific Title of Study
|
Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy volunteers – a randomized placebo controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajkumar S Amaravati |
| Designation |
Professor |
| Affiliation |
St. Johns Medical College, Bangalore |
| Address |
Department of Orthopaedics,
St. Johns Medical College Hospital, bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9945138739 |
| Fax |
|
| Email |
rajkumar_as@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeffrey Pradeep Raj |
| Designation |
PG demonstrator |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Pharmacology
St. Johns Medical College
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
8095464464 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeffrey Pradeep Raj |
| Designation |
PG demonstrator |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Pharmacology
St. Johns Medical College
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
8095464464 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Private Limited, Plot No. 5B, Veerasandra Indl. Area,
19th K. M. Stone,
Hosur road, Electronic City Post,
Bangalore, 560100.
|
|
|
Primary Sponsor
|
| Name |
Natural Remedies Private Limited |
| Address |
Plot No. 5B, Veerasandra Indl. Area,
19th K. M. Stone,
Hosur road, Electronic City Post,
Bangalore, 560100.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajkumar S Amaravati |
St. Johns Medical College |
Sarjapura Road
Bangalore - 560034
Bangalore
KARNATAKA |
9945138739
rajkumar_as@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Johns Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Identical looking placebo capsule once daily orally for 84 days |
| Intervention |
Turmacin 0.5g |
Turmacin capsule 0.5g oral once daily for 84 days |
| Intervention |
Turmacin 1g |
Turmacin 1g capsule once daily orally for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Joint pain reported on visual analogue scale |
days 5,7,28,56,84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| isometric and isokinetic knee extension for quadriceps and hamstrings at various angular velocity (60 degree/sec to 300 degree/sec) |
Days 1 & 84 |
| Maximal isometric torque will be measured with knee extension from the knee flexed (90 degree) position |
Days 1 & 84 |
| Isokinetic strength assessed in different velocities in random order |
Days 1 & 84 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2018 |
| Date of Study Completion (India) |
28/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Raj JP, Venkatachalam S, Racha P, Bhaskaran S, Amaravati RS. Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants – a randomized placebo-controlled trial. CTIM. 2020;doi.org/10.1016/j.ctim.2020.102522 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Objective: Curcuma longa
has been widely used in Ayurveda for its medicinal properties and Turmacin was
developed from C. longa as a standardized extract containing
turmerosaccharides. In this clinical trial, the effect of Turmacin on
knee joint discomfort in healthy adults subjected to strenuous physical
activity was evaluated.
Design: Double-blind, triple-arm,
parallel-group, randomized placebo-controlled trial.
Setting: Healthy participants from an urban
tertiary care teaching hospital
Intervention: Healthy participants were randomized
in 1:1:1 ratio to receive either Turmacin 0.5g/1g or placebo once daily for 84
days. The participants were subjected to 10-minute strenuous exercise.
Outcome measures: Time to initial pain, final pain
score on a visual analogue scale, range of movement (ROM) of knee and the force
of contractions of muscles around the knee joint.
Results: A total of n=90 participants were
recruited. The mean
final pain scores were significantly lower in the Turmacin 1g and Turmacin 0.5g
when compared with the placebo from day-7 and day-5 onwards respectively. The
survival analysis consistently showed a decreased hazard for early onset of
pain in both the Turmacin groups. On day-84, the difference in mean ROM between
Turmacin 0.5g and placebo was 4.79 degrees (p=0.008) and that for Turmacin 1g
and placebo was 2.34 degrees (p=0.306). The difference in muscle force for
isokinetic contractions of the quadriceps at angular velocities of 120 and 180
was significant between Turmacin 0.5g and placebo (p=0.002 and p=0.005
respectively) while that for Turmacin 1g & Turmacin 0.5g (p=0.206 and
p=0.414 respectively) and Turmacin 1g & Placebo (p=0.046 and p=0.037) were
not significant. However, in the within group analysis participants in Turmacin
1g group had better preserved muscle functions than Turmacin 0.5g group at
angular velocities of 120 and 180 when compared with placebo.
Conclusion: Turmacin (0.5g and 1g) was efficacious when compared to
placebo in increasing the pain threshold and knee ROM in healthy participants with
minor adverse events.
|