| CTRI Number |
CTRI/2024/07/070176 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate
the efficacy of JUVECOL K for period of 16 weeks in improving Knee Joint Health |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo Controlled Trial to evaluate the efficacy of JUVECOL K in improving knee joint health. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NT/JH/PG/24 version 1.0 Dated 03 Jan 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anurag Rai MS Ortho |
| Designation |
Consultant Orthopedics |
| Affiliation |
Lifeline Hospital and Research Centre |
| Address |
Lifeline Hospital and Research Centre, 1st Floor, Room No 8, 496, Madya, Azamgarh, Uttar Pradesh.
Azamgarh
UTTAR PRADESH
276001
India |
| Phone |
6305647321 |
| Fax |
|
| Email |
drorthodoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurtulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals, Room No 13 Ground Floor R&D Block Survey No 181 by 2 JRD Tata Industrial Estate Kanuru, Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
|
| Email |
drgt@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Alluri Venkata Krishna Raju |
| Designation |
General Manager |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals, Room No 17 Ground Floor R&D Block Survey
No 181 by 2 JRD Tata Industrial Estate Kanuru, Vijayawada
Krishna
India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
|
| Email |
avkr@lailanutra.in |
|
|
Source of Monetary or Material Support
|
| Naturetech Co., Ltd. 450-86, Maebong-ro, Byeongcheon-myeon, Dongnam-gu,Cheonan-si, Chungcheongnam-do, Republic of Korea |
|
|
Primary Sponsor
|
| Name |
Naturetech co Ltd |
| Address |
450-86, Maebong-ro, Byeongcheon-myeon, Dongnam-gu,
Cheonan-si, Chungcheongnam-do, Republic of Korea, Korea |
| Type of Sponsor |
Other [Nutraceutical industry] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutraceuticals |
40-15-14, Brindavan Colony, Labbipet Vijayawada-520 010 Andhra Pradesh, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anurag Rai MS Ortho |
Lifeline Hospital and Research Centre |
Room no 8, 1st Floor, Department of orthopedics, Lifeline Hospital and Research Centre, 496, Madya
Azamgarh
UTTAR PRADESH |
6305647321
drorthodoc@gmail.com |
| Dr Ram Bachan Tripathi MS Ortho |
Vijay Super Specialty Hospital |
Ground Floor, Room no 3. Orthopedics Departments, Vijay Super Specialty Hospital
Gandhinagar Colony, Laxirampur
Azamgarh
UTTAR PRADESH |
9494532963
tripathirb60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee Life Line Hospital for Lifeline Hospital and Research Centre |
Approved |
| Ethics Committee Life Line Hospital for Vijay Super Specialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Juvecol K |
One capsule (50 mg) will be taken orally with water once daily after breakfast for duration of 16 Weeks |
| Comparator Agent |
Placebo |
One capsule (50 mg) will be taken orally with water once daily after breakfast for duration of 16 Weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects aged between 40-70 years with body mass index (BMI) of 18.5 - 29.9 kg/m2
2.Subjects with radio graphic evidence by Kellgren-Lawrence grade 1 or 2
3.One knee joint (or most painful knee joint among the two) with a VAS score of 30-70 mm
4.Subjects with sedentary lifestyle, no regular athletic or sports activities
5.Subject agrees to maintain diet tracker
6.Subject considered generally healthy as per health history and routine clinical investigations during screening.
7.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit
8.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Routine use of dietary supplements containing proteoglycans,hyaluronic acid, N-acetyl glucosamine, glucosamine,chondroitin sulfate, collagen peptides, Curcumin, Boswellia or any other constituents of the test supplement within 3 months prior to enrolment
2.Subjects with any possible signs/ indications/ history of arthritis, joint disorders including dislocations and quadriceps tendons tear
3.History of underlying inflammatory arthropathy or Gout or severe RA or OA
4.Clinical history of bone or cartilage disorders including fracture and distortion within one year prior to enrolment
5.Have taken any Intra-articular or Oral corticosteroids,indomethacin, glucosamine +
chondroitin, within 3 monthsprior to screening visit (Visit 1) or intra-articular treatment/injections with hyaluronic acid within 6 months preceding the treatment period.
6.Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation
7.Expectation of surgery during the study duration period.
8.Female subjects, who are pregnant, breast feeding or planning to become pregnant
9.Fasting blood glucose level should be greater than 125 mg/dl.
10.Subject having known allergy to non-steroidal antiinflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to investigational product or any other related products
11.Have taken acetaminophen/ paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the screening visit (Visit 1)
12.Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders
13.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol
14.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent
15.History of congestive heart failure or any vascular conditions.
16.Subjects with HIV Positive status.
17.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
18. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
neurologic diseases, or malignancies, hypothyroidism
19.History of Systemic Lupus Erythematous (SLE)
20.Subjects consuming alcohol (Greater than 5 drinks per week) and smoking greater than 5 cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
21.Any other condition that, in the opinion of the investigator, would adversely affect the subject‟s ability to complete the study or its measures.
22.Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening
|
|
|
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 |
| Change from baseline to the end of the study period in total WOMAC score |
Day 1 (Baseline), Week 2, Week 4,Week 8, Week 12 & Week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Visual Analogue Scale (VAS) |
Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 |
| Change from baseline to the end of the study period in total in WOMAC subscales (pain, stiffness and physical function) |
Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 |
| Change from baseline to the end of the study period in Timed Up and Go test (TUG) |
Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 |
| Change from baseline to the end of the study period in Six-minute walk test (SMWT) |
Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 |
| Change from baseline to the end of the study period in Knee flexion range of motion |
Day 1 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16 |
| Change from baseline to the end of the study period in Joint space (using Digital X-ray) |
Screening & Week 16 |
| Change from baseline to the end of the study period in Physician Global Assessment (PGA) and Subjective Global Assessment (SGA) |
Week 2,Week 4,Week 8 ,Week 12 & Week 16 |
| Change from baseline to the end of the study period in Global physical activity questionnaire (GPAQ) |
Day 1 (Baseline ) ,Week 2,Week 4,Week 8 ,Week 12 & Week 16 |
| Change from baseline to the end of the study period in Urinary levels of CTX II |
Day 1 (Baseline ) & Week 16 |
| Change from baseline to the end of the study period in Serum cytokine levels (IL-6, IL-1β, TNF-α, MMP-3 levels) |
Day 1 (Baseline ) & Week 16 |
| Change from baseline to the end of the study period in Serum cartilage biomarker-Cartilage Oligomeric Matrix Protein (COMP) |
Day 1 (Baseline ) & Week 16 |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The purpose of this study is to evaluate the efficacy of proteoglycan (JUVECOL K) in improving Knee joint health. Enrolled subjects will receive either JUVECOL K or Placebo for 16 weeks. Study consists of 7 visits (including screening visit). Subjects shall be Randomised to either Juvecol K or Placebo on Day 1 and subsequently subjects shall be informed to visit the site for the follow up visits (i.e. Week 2, Week 4, Week 8, Week 12 and Week 16). |