| CTRI Number |
CTRI/2025/02/080777 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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 evaluate the efficacy of herbal formulation in subjects with mild Osteoarthritis |
|
Scientific Title of Study
|
A Randomized, double-blind, placebo-controlled study to evaluate the efficacy of herbal formulation in subjects with mild Osteoarthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/OA/LI51202F1/24 Version 1.0 Dated 08 Aug 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Kumar Upadhyay |
| Designation |
MBBS, MS - Orthopedic |
| Affiliation |
Rambilas Panacea Hospital |
| Address |
Room 1, Ground floor Rambilas Panacea Hospital
Chandpur, Industrial Estate Rd, Lehertara Industrial Estate, Varanasi, Churamanpur, Uttar Pradesh 221107
Varanasi
UTTAR PRADESH
221107
India |
| Phone |
9415089849 |
| Fax |
|
| Email |
rbhospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurthulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
Laila nutraceuticals |
| Address |
Room No 13 Ground floor Laila Nutraceuticals
R&D Survey no 181 by JRD Tata Industrial Estate kanuru
Vijayawada-520007
India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.com |
|
Details of Contact Person
Public Query
|
| Name |
Alluri Venkatakrishna Raju |
| Designation |
General Manager |
| Affiliation |
Laila nutraceuticals |
| Address |
Room No 17 Ground floor
Laila Nutraceuticals
R&D Survey no 181 by JRD Tata Industrial Estate kanuru
Vijayawada-520007
India
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
avkr@lailanutra.com |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals R&D Block Survey No 181 by 2 JRD Tata lndustrial Estate Kanuru
vijayawada Krishna District Andhra pradesh 520007 lndia |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
40-15-14, Brindavan Colony, Labbipet,
Vijayawada-520010
|
| Type of Sponsor |
Other [nutraceuticals Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Kumar Upadhyay |
Rambilas Panacea Hospital |
Chandpur, Industrial Estate Rd, Lehertara Industrial Estate, Varanasi, Churamanpur, Uttar Pradesh 221107
Varanasi
UTTAR PRADESH |
9415089849
rbhospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shiv Nath Hospital |
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 |
LI51202F1 |
One capsule daily after breakfast with
water for 30 days |
| Comparator Agent |
Placebo |
One capsule daily after breakfast with water for 30 days |
|
|
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 Knee osteoarthritis grade II of Kellgren and Lawrence assessed based on X-ray.
3. One knee joint (or most painful knee joint among the two) with a VAS score of 40-70 mm.
4. Subjects with sedentary lifestyle, no regular athletic or sports activities.
5. Subject agrees to maintain diet tracker.
6. Results of screening should be within normal range or considered not clinically significant by the Principal Investigator.
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.
9. Subject agrees to avoid 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 for the duration of the study.
10. Subject agrees to avoid use of medications for pain, including NSAIDS and any other oral or topical pain relief product with the exception of the rescue medication provided by the study site.
|
|
| 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 severe 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, glucosamine + chondroitin, within 3 months prior 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. Fasting blood glucose level greater than 125 mg/dl.
9. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
10. Subject having known allergy or suspected hypersensitivity or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or investigational product or any other herbal 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. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
18. Subjects consuming alcohol (less than 2 drinks per week) and smoking greater than 5 cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
19. Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
20. Subjects who have 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
WOMAC (pain)
|
Day 1 Baseline,Day 5,Day 15 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Visual Analogue Scale (VAS) |
Day 1 Baseline, Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in WOMAC (stiffness, physical function and Total score) |
Day 1 Baseline, Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in 30 sec Chair Stand Test (CST) |
Day 1 Baseline, Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in 6-minute walk test (SMWT) |
Day 1 Baseline, Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in Stair climb test (SCT) |
Day 1 Baseline, Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in Knee flexion/extension range of motion |
Day 1 Baseline, Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in Physician Global Assessment (PGA) and Subjective Global Assessment (SGA) |
Day 5,Day 15 and Day 30 |
| Change from baseline to the end of the study period in serum biomarkers hs CRP and TNF alpha |
Day 1 Baseline and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
27/02/2025 |
| 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="4"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 the study is to evaluate the efficacy of LI51202F1 in subjects with mild osteoarthritis and the subjects will be adminstered with either test or placebo orally for 30 days after breakfast. |