| CTRI Number |
CTRI/2024/12/078207 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To test the Effect of Curcumin in osteoarthritis and low back ache pain |
|
Scientific Title of Study
|
A Randomized double blinded comparative clinical study to evaluate the efficacy and safety of Curcumin (20 percentage SR and 95 percentage IR) in osteoarthritis and patients with low back ache. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CURCUMIN/29/24; Version: 1.0; Dated: 25-11-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan MBBS MD |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
DK Elite Health Care Centre, Room no. 1,First Floor, No.370, Cuddalore main Road, Nainarmandapam, Puducherry
Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MBBS MD |
| Designation |
Consultant |
| Affiliation |
Ki3 Private Limited |
| Address |
DK Elite Health Care Centre, Room no. 1,First Floor, No.370, Cuddalore main Road, Nainarmandapam, Puducherry
Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 PRIVATE LIMITED |
| Address |
Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| MAKAMS Industries Private Limited, F-12, ADARSHINI PLAZA, 91, ADCHINI, SRI AUROBINDO MARG, , NEW DELHI, Delhi, India - 110017 |
|
|
Primary Sponsor
|
| Name |
MAKAMS Industries Private Limited |
| Address |
F-12, ADARSHINI PLAZA, 91, ADCHINI, SRI AUROBINDO MARG, , NEW DELHI, Delhi, India - 110017 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 M Sakthi Balan MBBS MD |
DK Elite Health Care Centre |
DK Elite Health Care Centre, Room no 01, Pharmacologist, First Floor, No.370, Cuddalore main Road, Nainarmandapam,
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
| Dr Bhuvanesh MBBS DNB Orthopaedics |
Sri Ortho Care |
No. 6, Opposite to KBSN, Buvan Kare Street, Karamanikuppam-605004 (Opposite to KBSN)
Pondicherry
PONDICHERRY |
8667437604
bhuvaneshg27@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethique De La Nature Association |
Approved |
| Ethique De La Nature Association |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Curcumin 95% (IR form), Reference: nil, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 95(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Curcumin 20% (SR form), Reference: nil, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 20(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Comparator Curcumin 95%, Reference: nil, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 95(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm (Non Ayurveda) | | - | Placebo | 1 capsule twice daily after food for 8 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria (Class III) and confirmed with X-rays and grade 3 or 4 as per Kellgren and Lawrence classification system and patients suffering from low back ache over the past 3 months.
2. Have been on stable dose of prescription Nonsteroidal Anti- Inflammatory Drugs (NSAIDS), or acetaminophen of at least 2000 mg per day for at least 20 days in the past month.
3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
4. Patient should have not participated in any other clinical trial during the past 3 months.
5. Patients, who are willing to give written, signed and dated informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Arthritis of the knee from other causes and Lumbar spondylosis.
2. Uncontrolled hypertension (180/100) or Diabetes (HbA1c greater than 10)
3. Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine
4. Moderate to severe renal impairment
5. Pregnant or lactating
6. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
7. Suffering from any illness which will interfere with present study as decided by clinical investigator
8. History of hypersensitivity to any of the test products.
9. Any condition decided as unfit for study by Clinical investigator
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline to 8 weeks in knee and back pain intensity measured by pain VAS Scale (0 to100 mm)
2. Change from baseline to 8 weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.
3. Changes from base line to 8 weeks in following laboratory parameter(s):
Hs C Reactive Protein
ESR
4. Change in baseline to 8 weeks in Patients Global Assessment of osteoarthritis and low back ache.
5. Number of patients with a response rate measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT OARSI).
6. Changes from baseline to 8 weeks in Quality of life- Questionnaires (Short Form Health 12). |
Day 0, week 4 and week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To demonstrate safety and tolerability of study product by clinical AEs, including laboratory abnormalities (If any)
Safety and tolerability evaluation criteria:
Adverse events and serious adverse events during the study period
Laboratory parameters- CBC, RFT, LFT, HbA1c and RBS (pre and post study)
|
Day 0 and week 8 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized study evaluates the efficacy and safety of Curcumin formulations in 100 patients with osteoarthritis and low back ache. Patients will receive Curcumin 20% (SR), Curcumin 95% (IR), placebo, or comparator Curcumin for 8 weeks. Outcomes include pain reduction, inflammation markers, quality of life, and safety through adverse events and lab parameters. |