| CTRI Number |
CTRI/2025/03/082495 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of herbal supplement in improving Knee Osteoarthritis. |
|
Scientific Title of Study
|
Efficacy of CL22202 in improving Knee Osteoarthritis: A Randomized, Double-Blind, Placebo Controlled Parallel-Group Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLS/OA/CL22202/24 Protocol Version 01, Dated 11-Nov-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annavarapu Tirupathi Rao |
| Designation |
Overall Trail Coordinator |
| Affiliation |
CLS Pvt Ltd |
| Address |
Department of Pharmacology, Room No-201, First Floor, Aswaraopet
Khammam
TELANGANA
507301
India |
| Phone |
08662464446 |
| Fax |
|
| Email |
tirupathionline@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annavarapu Tirupathi Rao |
| Designation |
Overall Trail Coordinator |
| Affiliation |
CLS Pvt Ltd |
| Address |
Department of Pharmacology, Room No-201, First Floor, Aswaraopet
Khammam
TELANGANA
507301
India |
| Phone |
08662464446 |
| Fax |
|
| Email |
tirupathionline@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ajjarapu Srinivasu |
| Designation |
Manager |
| Affiliation |
CLS Pvt Ltd |
| Address |
Department of Sales, Room No-101, Ground Floor, Aswaraopet
Khammam
TELANGANA
507301
India |
| Phone |
08662464446 |
| Fax |
|
| Email |
asrrvja@gmail.com |
|
|
Source of Monetary or Material Support
|
| CLS Pvt Ltd, Aswaraopet, Khammam District, Telangana-507301
|
|
|
Primary Sponsor
|
| Name |
CLS Pvt Ltd |
| Address |
Aswaraopet, Khammam District, Telangana-507301, India |
| Type of Sponsor |
Other [Herbal exports] |
|
|
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 Kinthala Kishor |
Great Eastern Medical School & Hospital |
Department of Orthopedics, Hospital Block. Ground Floor, Unit: II, Great Eastern Medical School & Hospital, A unit of Aditya Educational Society, Ragolu, Pin: 532484
Srikakulam
ANDHRA PRADESH |
7893488169
drkkishorresearch@gmail.com |
| Dr S Nawazish Rabbani |
NUHA Hospitals |
Department of Orthopedics, Room No: 1, First Floor, Nuha Hospitals, 12-19-61 & 62, Old Bank Road, Kothapeta, Pin : 522001.
Guntur
ANDHRA PRADESH |
9985511327
dr.nawazish@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Great Eastern Medical School and Hospital for Dr. Kinthala Kishor |
Approved |
| Institutional Ethics Committee-NUHA Hospitals for Dr. Shaik Nawazish Rabbani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CL22202 |
200 mg per day, One capsule daily in the morning after breakfast for 120 days |
| Comparator Agent |
Placebo |
One capsule daily in the morning after breakfast for 120 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Ambulatory, male and female subjects aged 45-70 years with a Body Mass Index (BMI) of 22 to 29 kg/m².
2.Subjects diagnosed with Knee osteoarthritis grade II of Kellgren and Lawrence based on X-ray.
3.Subjects experiencing knee pain of 40-70 mm on a 100 mm visual analog scale (VAS).
4.Willing to refrain from using glucosamine, chondroitin, MSM, boswellia, turmeric, any other joint supplements, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDs (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
5.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
6.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
7.Subjects to discontinue the use of supplementations including vitamins, any other joint supplements, herbals, or other topical applications.
8.Agree to participate in the study through a written informed consent.
9.Willing to comply with all study-related activities.
10.No history of rheumatoid arthritis.
11.No bilateral end-stage knee OA.
|
|
| ExclusionCriteria |
| Details |
1.Previous injury and/or surgery to the knee.
2.Subjects who underwent treatment for COVID-19 within the last 3 months or tested positive during the study.
3.Expectation of surgery during the study period.
4.Subjects with uncontrolled Diabetes (FPG greater than 126 mg/dL) and Hypertension (Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg).
5.Subjects suffering from COPD or with a history of any respiratory or breathing disorders.
6.Subjects who have used any immunosuppressive drugs in the last 6 months (including steroids or biologics) or those with a history of immune system and autoimmune disorders or diseases, including Systemic Lupus Erythematous (SLE).
7.Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
8.Subjects with known allergies to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, or who have a suspected hypersensitivity, allergy, or sensitivity to herbal products.
9.Subjects who have taken acetaminophen/paracetamol, ibuprofen, aspirin, or other NSAIDs, or any herbal products within 7 days prior to the screening visit (visit 1).
10.Subjects who have taken any corticosteroid, indomethacin within 1 month prior to enrollment, or intra-articular treatment/injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
11.History of congestive heart failure or any vascular conditions.
12.Subjects with HIV positive status.
13.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
14.Alcohol intake greater than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers (greater than 5 cigarettes per day).
15.History of psychiatric disorders that may impair the ability of subjects to provide written informed consent.
16.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
17.History of heart, liver, lung cancer or chronic diseases.
18.Allergies to any ingredient in the investigational products.
19. Subjects with history of knee replacements.
20.Subjects currently engaged in a weight loss program or using weight loss medications.
21.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures
|
|
|
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 |
| Change from baseline to the end of the study period in : Total WOMAC score |
Days 1, 14, 30, 60, 90 and 120
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in:
WOMAC subscales (pain, stiffness, physical function)
|
Days 1, 14, 30, 60, 90 and 120
|
Pain using Visual Analogue Scale (VAS) - 100 mm
|
Screening Visit, Days 1, 14, 30, 60, 90 and 120 |
Lequesne’s Functional Index (LFI)
|
Days 1, 14, 30, 60, 90 and 120 |
Six-minute walk test (SMWT)
|
Days 1, 30, 60, and 120 |
Chair stand test (30SCST)
|
Days 1, 30, 60, and 120 |
Primary Knee flexion range of motion
|
Days 1 and 120 |
Isometric Knee torque (using EasyForce dynamometer)
|
Days 1, 30, 60, and 120 |
Perceived Stress Scale (PSS-10)
|
Days 1, 14, 30, 60, 90 and 120 |
Athens Insomnia Scale (AIS)
|
Days 1, 14, 30, 60, 90 and 120 |
Kellgren and Lawrence grade
|
Screening Visit and 120 |
Quality of life Short Form-36 (SF-36) questionnaire
|
Days 1, 30, 60, and 120 |
Memory questionnaire (Mini-Cog©)
|
Days 1, 30, 60, and 120 |
Serum Biomarkers (hs-CRP, TNF-alpha, MMP-3, COMP-1 and IL-6)
|
Days 1 and 120 |
Urinary CTX-II (normalized by Creatinine)
|
Days 1 & 120 |
Total Anti-Oxidant Capacity (TAC)
|
Days 1 and 120 |
| Use of Rescue medication |
Days 1, 14, 30, 60, 90 and 120 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2025 |
| Date of Study Completion (India) |
28/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The purpose of this study is to evaluate the efficacy and tolerability of CL22202 in improving Knee Osteoarthritis. A total of 100 Ambulatory, male and female subjects aged between 45 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either CL22202 - 200 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 120 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL22202 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
|