| CTRI Number |
CTRI/2020/03/023877 [Registered on: 11/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To know the effect and safety of turmeric extract capsule in healthy adults having severe knee joint pain |
|
Scientific Title of Study
|
A prospective Double Blind, Randomized, Multi-Center, Parallel Group,Two Arm, Placebo-Controlled trial to evaluate the efficacy and safety of TurmXtra 60N (Water Dispersible Turmeric Extract) Capsule in healthy adults having Chronic Knee Joint Pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRO-INV-012-19 Version 01 Dated 22 Jan 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay |
| Designation |
Principal Investigator |
| Affiliation |
Sri Venkateshwara Hospitals |
| Address |
Sri Venkateshwara Hospitals
Room No 206 2nd Floor
No-27 29 Main Road Rashtra Kuvempu Nagara BTM 2nd stage bengaluru
Bangalore
KARNATAKA
560076
India |
| Phone |
9972352265 |
| Fax |
|
| Email |
vinaynbmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethi S |
| Designation |
Medical Monitor |
| Affiliation |
Invitro Research Solutions Pvt. Ltd |
| Address |
InVitro Research Solutions Pvt Ltd
Room No 201 2nd floor
22, 23 Kodigehalli Main road sahakar nagar hebbal
Bangalore
KARNATAKA
560092
India |
| Phone |
9900515364 |
| Fax |
|
| Email |
preethi@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vijay Bhaskar |
| Designation |
Associate Director |
| Affiliation |
Invitro Research Solutions Pvt. Ltd |
| Address |
InVitro Research Solutions Pvt Ltd
Room No 302 3rd floor
22, 23 Kodigehalli Main road sahakar nagar hebbal
Bangalore
KARNATAKA
560092
India |
| Phone |
6366575282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Ltd
& Laila Nutraceuticals |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Ltd |
| Address |
Unit 703, 704, 7th Floor, Hubtown Solaris, N.S Phadke Marg, Andheri East, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutraceuticals |
40-15-14, Brindavan Colony, Vijayawada, Andhra Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pandurangaiah Srinivas |
Shettys Hospital |
Shettys Hospital
Plot No 11, 12th F Main Road, Kaveri Nagar, Bommanahalli , Bengaluru
Bangalore
KARNATAKA |
8861245971
srinivas_pandurangaiah@rediffmail.com |
| Dr Vinay N |
Sri Venkateshwara Hospitals |
No-27, 29 Main Road, Rashtra Kuvempu Nagara, BTM 2nd stage , BTM Layout Bengaluru
Bangalore
KARNATAKA |
9972352265
vinaynbmc@gmail.com |
| Dr Shiva Kumar BR |
Surya Medical Centre |
Surya Medical Centre
# 5,8th cross , Mariyappa Road, Near Kullappa Circle, Bengaluru
Bangalore
KARNATAKA |
9900329850
brdrshivakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Shettys Ethics Committee |
Approved |
| Shettys Ethics Committee |
Approved |
| Sri Ventakeshwara Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Knee Joint Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One Capsule per day within one hour of lunch for 90 Days |
| Intervention |
TurmXtra 60N |
One Capsule per day within one hour of lunch for 90 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects aged between 18-60 years with BMI 18 to 30 kg/m2 and with chronic knee joint pain (at least past 2 months).
2.Subjects having moderate pain i.e. visual analogue score of 4 or greater in the knee joint.
3.Subjects willing to use ongoing analgesic drugs and/or anti inflammatory drug only as rescue medication until study completion.
4.Subject provides written informed consent and comes for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
2.Post-menopausal female subjects
3.Subjects who are suffering from arthritis of the knee as diagnosed over X-ray
4.Subjects who have taken more than two analgesic drugs and/or anti-inflammatory for more than three months
5.Subjects who have a history of surgery or trauma affecting the knee.
6.Impaired renal function; eGFR<60mls/min/1.73m2.
7.Impaired liver enzymes
8.Presence or history of any chronic illness including but not limited to psychiatric, cardiovascular, pulmonary, neurological, hepatic, renal, metabolic, and ophthalmologic including HIV and AIDS taking regular pharmacological agents.
9.History of drug dependence or any severe co-morbid medical conditions.
10.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine/Caffeine dependence.
11.Subjects on multivitamins/herbal supplements/ any other wellness product
12.Subject who has participated in a clinical study within the last 30 days prior to entering this study.
13.Subject with hypersensitivity to any of the ingredients of the study products.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Change in Pain Visual Analogue Scale (VAS) |
Day 1, Day 45 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in 9-step Stair Climb Test
2. Improvement in 80 meter fast paced walk test
3.Primary Knee flexion
4.Biochemistry
|
Day 1, Day 45 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2020 |
| Date of Study Completion (India) |
24/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total 106 healthy, adult human subjects will be enrolled in the study. They will be divided in to two arms. i.e Active and placebo arm and followed up for 3 months. The Primary objective of the study is to evaluate the efficacy and safety of turmeric Extract capsules in chronic knee joint pain |