FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101526 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of LN21194 in improving Knee Osteoarthritis 
Scientific Title of Study   A Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Efficacy of LN21194 in Improving Knee Osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
LN/OA/LN21194/25 Version 01 Dated 02-May-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikram Nigam 
Designation  Principal Investigator 
Affiliation  Swaroop Rani Hospital,  
Address  Room No. 1 Dept of Orthopedics, Motilal Nehru Medical College, M G Road, Prayagraj

Allahabad
UTTAR PRADESH
211002
India 
Phone  9453460474  
Fax    
Email  drvikramnugam@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurtulu  
Designation  Senior Vice President Technical  
Affiliation  Laila Nutra Private Limited 
Address  D.No. 40-15-14,Sudarsan, Apartment, Brindavan Colony, Chandramoulipuram, Vijayawada (Urban),

Krishna
ANDHRA PRADESH
520010
India 
Phone  8666668001  
Fax    
Email  drgt@lailanutra.in   
 
Details of Contact Person
Public Query  
Name  Dr A V Krishna Raju 
Designation  General Manager–R & D 
Affiliation  Laila Nutra Private Limited 
Address  D.No. 40-15-14,Sudarsan, Apartment, Brindavan Colony, Chandramoulipuram, Vijayawada (Urban),

Krishna
ANDHRA PRADESH
520010
India 
Phone  8666668001  
Fax    
Email  avkr@lailanutra.com  
 
Source of Monetary or Material Support  
Laila Nutra Private Limited D.No.40-15-14,Sudarsan, Apartment,Brindavan Colony, Chandramoulipuram, Vijayawada (Urban), Krishna- 520010, Andhra Pradesh 
 
Primary Sponsor  
Name  Laila Nutra Private imited 
Address  D.No.40-15-14,Sudarsan, Apartment,Brindavan Colony, Chandramoulipuram, Vijayawada (Urban), Krishna- 520010, Andhra Pradesh 
Type of Sponsor  Other [Nutraceuticals] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Nigam  Swaroop Rani Hospital  Dept. of Orthopedics, Motilal Nehru Medical College, M G Road, Prayagraj-211002
Allahabad
UTTAR PRADESH 		 9453460474

drvikramnugam@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MLN Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LN21194- 200 mg   One capsule per day in the morning after breakfast with water for 30days. 
Comparator Agent  Placebo  One capsule per day in the morning after breakfast with water for 30days. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Ambulatory, male and female subjects aged 40-75 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 analogue 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 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 or 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 or 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 more than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers (more 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 bilateral 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, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Pain using Visual Analogue Scale (VAS) - 100 mm   Screening, Baseline, Day 5, Day 15 and Day 30  
 
Secondary Outcome  
Outcome  TimePoints 
Change in WOMAC Total & subscales (pain, stiffness, physical function)   Baseline, Day 5, Day 15 and Day 30  
Change in Lequesne’s Functional Index (LFI)   Baseline, Day 5, Day 15 and Day 30  
Change in Six Minute Walk Test (SMWT)  Baseline, Day 5, Day 15 and Day 30  
Change in Chair stand test (30s CST)  Baseline, Day 5, Day 15 and Day 30  
Change in Primary Knee flexion range of motion  Baseline, Day 5, Day 15 and Day 30  
Change in Isometric knee torque using Easy force dynamometer  Baseline, Day 5, Day 15 and Day 30  
Change in Psychological General Wellbeing Index (PGWBI)  Baseline, Day 5, Day 15 and Day 30  
Change in PGA & SGA (Physician Global Assessment & Subjective Global Assessment)   Day 5, Day 15 and Day 30  
Change in Serum Biomarkers (hs CRP, IL-6 and PGE-2)  Baseline and Day 30  
Use of rescue medication  Baseline, Day 5, Day 15 and Day 30  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/01/2026 
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="0" 
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 the study is to evaluate the efficacy of LN21194 in improving knee osteoarthritis. A total of 80 male and female subjects aged between 40 and 75 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 LN21194-200mg or Placebo arm at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water for 30days. Apart from primary and secondary outcomes, the study will also record the vital sign and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN21194 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. 
Close