| CTRI Number |
CTRI/2023/11/060117 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| 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 test the product with curcumin-based derivative in patients with joints pain of knee |
Scientific Title of Study
Modification(s)
|
A double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 20% Turmeric Extract in patients with Joint pain of the knees |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Navaladi Shankar |
| Designation |
Principal Investigator |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Orthopaedics Ground Floor 21 Greams Lane Off Greams Road Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
914428293333 |
| Fax |
|
| Email |
drnavaladi_s@apollohospitals.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial Area
Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Satish G |
| Designation |
Vice President |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial Area
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami Sabinsa Group Limited
19 1 19 2 I Main II Phase Peenya Industrial Area
Bangalore |
|
|
Primary Sponsor
|
| Name |
Sami Sabinsa Group Limited |
| Address |
19 1 & 19 2 I Main II Phase Peenya Industrial Area
Bangalore |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Navaladi Shankar |
Apollo Hospitals |
Department of Orthopaedics Ground Floor 21 Greams Lane Off Greams Road Chennai
Chennai
TAMIL NADU |
914428293333
drnavaladi_s@apollohospitals.com |
| Dr Santosh |
Santosh Hospital |
6 PromenadeRoad,BehindColesPark Bangalore
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SantoshInstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M129||Arthropathy, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
20% Turmeric Extract |
Capsule containing 500mg Curcumin derivative twice a day after breakfast and dinner for 90 days |
| Comparator Agent |
Microcrystalline cellulose |
Capsule containing 500mg microcrystalline cellulose twice a day after breakfast and dinner for 90 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female participants whose age ≥30 and ≤ 65 years.
2. Participants must provide a written and signed informed consent and comply with requirements of the study.
3. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
4. HsCRP level ≥ 3mg/L.
5. Patient with mild to moderate pain in knees.
6. Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications.
7. Patients with the pain perception ranging from 30 to 60 based on VAS (Visual Analog Scale) of 0 – 100mm.
|
|
| ExclusionCriteria |
| Details |
1. Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection.
2. Patients with a history of knee or hip replacement surgery.
3. Treatment of knee joint pain with intra-articular injection of corticosteroids within the last 3 months preceding study.
4. Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor.
5. Patient with history of Asthma or on medication with Ipratropium Bromide.
6. Patients undergoing treatment for any other systemic illness.
7. Medication:
i. Participants who have used the following substances within 1 week prior to screening – glucosamine sulfate, chondroitin sulfate, NSAID, glucocorticoids, or steroids.
ii. Participant who have used hyaluronate within a month prior to screening.
iii. Participants who have used any of the below dietary supplements within the past 30 days – Boswellia, Omega3, Collagen, Curcumin etc
8. Pregnant, Lactating Women & women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study.
9. History of chronic smoking and Alcoholics.
10. Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period.
11. Any other condition/reason which the Principal Investigator thinks may jeopardize the study.
|
|
|
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 |
1 Mean change in KOOS score
2 Mean change in VAS Pain Scale |
1 Randomisation Day to Day 90
2 Screening Day to Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Mean change in the HsCRP
2 Mean change in IL-6
3 Mean change in ESR
4 Mean change in KOOS Score for pain, stiffness & function subscale during the study
5 Mean change in the range of movement by Goniometer
6 Safety as determined through changes in lab test results and incidence of adverse events during the study period in both arms |
1 Screening Day to Day 90
2 Randomisation Day and Day 90
3 Screening Day and Day 90
4 Randomisation Day to Day 90
5 Screening Day to Day 90
6 Screening Day to Day 90 and telephonic follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/12/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study involves 60 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either 20% turmeric extract500mg or Placebo (Microcrystalline cellulose-500mg) Arm-2. Specific biomarkers such as IL-6, HsCRP, ESR will be measured and analysed during the study period. Goniometer and scales such as modified WOMAC and KOOS will be also analysed during the study period. The final statistical analysis and study report will be complied at the end of the study period. |