| CTRI Number |
CTRI/2025/07/092032 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Smoothwalk Tablets in Reducing the Symptoms of Knee Osteoarthritis |
|
Scientific Title of Study
|
A Prospective, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Smoothwalk Tablets in Reducing the Symptoms of Knee Osteoarthritis. |
| Trial Acronym |
CP-SMW001-25 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabhakar Kolkamuri |
| Designation |
Sr. Director |
| Affiliation |
Techsol Life sciences Private Limited |
| Address |
CRO Services Division, No:845, Road No: 45
Ayyappa Society, Madhapur
Hyderabad
TELANGANA
500081
India |
| Phone |
9741766881 |
| Fax |
|
| Email |
prabhakar.kolamuri@techsollifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakar Kolkamuri |
| Designation |
Sr. Director |
| Affiliation |
Techsol Life sciences Private Limited |
| Address |
CRO Services Division, No:845, Road No: 45
Ayyappa Society, Madhapur
Hyderabad
TELANGANA
500081
India |
| Phone |
9741766881 |
| Fax |
|
| Email |
prabhakar.kolamuri@techsollifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmana Kumar Jakkala |
| Designation |
Co-Founder & Senior Vice President |
| Affiliation |
Techsol Life sciences Private Limited |
| Address |
CRO Services Division, No:845, Road No: 45
Ayyappa Society, Madhapur
Hyderabad
TELANGANA
500081
India |
| Phone |
9000782176 |
| Fax |
|
| Email |
laxman.jakkala@techsollifesciences.com |
|
|
Source of Monetary or Material Support
|
| LEE HEALTH DOMAIN (I) PVT. LTD. |
|
|
Primary Sponsor
|
| Name |
LEE HEALTH DOMAIN (I) PVT. LTD. |
| Address |
Survey No. 257 & 258/1, Door No. 11-6/56-C,
Moosapet, Hyderabad,
Telangana 500037, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrM A V V Prasad |
Banu Hospital - A Unit of PCRI Hospitals Pvt Ltd |
1st Floor Room No: 203, l-53 Srinagar Padugupadu
Before NH 67, NTS Railwaygate
Nellore
ANDHRA PRADESH |
9885226009
0862225699
mavvprasad.vijaya@gmail.com |
| Dr M Venkata Roopesh |
Vijaya Super Speciality Hospital |
OPD Room NO: 08
16 -lll4l A, Raghava Cine Complex Road,
Pogathota
Nellore
ANDHRA PRADESH |
8612321828
vijaya.nel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PCRI ETHICS COMMITTEE |
Approved |
| PCRI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Smoothwalk |
Smoothwalk is administered orally twice daily with lukewarm water, before meals. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged greater than or equal to 45 years
2. Subjects who are diagnosed with Osteoarthritis and confirmed x-rays showing radiographic evidence consistent with Kellgren-Lawrence Grade 2 or 3 as per Annexure 1.
3. Primary OA according to American College of Rheumatology (ACR) clinical and radiographic criteria as per Annexure 2
4. Subjects who understand the nature of the study and provide written informed consent
5. Subjects who are cooperative, reliable, and agree to comply with protocol procedures
6. Women of childbearing potential must have a negative pregnancy test at screening, or have had a hysterectomy, or have gone through menopause for more than 2 years |
|
| ExclusionCriteria |
| Details |
1.Pregnancy, lactation, or planning pregnancy during the study period.
2.Individual intolerance to the active or excipients of the dietary supplement - Smoothwalk Tablets (collagen type II + Natural Eggshell Membrane + Glucosamine Hydrochloride + Curcumin + Boswellia serrata extract + Calcium Ascorbate (vitamin C) + Vitamin D3).
3.Intolerance to eggs, poultry
4.History of trauma or surgery on the target joint other than diagnostic arthroscopy more than 60 days old at study entry, or expected surgery within 6 months following inclusion
5. Immune-inflammatory joint disease, rheumatoid arthritis, systemic connective tissue disease, systemic red lupus etc
6. Subjects with a history of gout
7. Presence or suspicion of drug, alcohol, or drug addiction
8. Use of glucocorticosteroids within 1 month prior to the baseline visit
9. Use of NSAIDs less than 3 weeks before baseline.
10. The need for stable use of glucocorticosteroids in any dosage form
11.Use of w-3 polyunsaturated fatty acid preparations in the 6 months prior to study participation (a 2-week washout period is allowed), therapeutic doses of fish or vegetable oils (greater than or equal to 2 g/day), shark cartilage preparations
12. Subjects suffering from any chronic illness that could interfere with the current study, as determined by the clinical investigator.
13. Participation in another clinical study at present or in the previous 30 days or 5 half-lives (whichever is longer) prior to the Screening Visit.
After assessment of the subject, subject inclusion will be at the discretion of the investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the mean total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of study visit 4 (Day 90 ± 3) compared to baseline. |
- Visit 1: Screening/Baseline
- Visit 2: Follow-up (Day 30 ± 3)
- Visit 3: Follow-up (Day 60 ± 3)
- Visit 4: End of Study (Day 90 ± 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the mean total score of VAS at the end of study visit compared to baseline. |
- Visit 1: Screening/Baseline
- Visit 2: Follow-up (Day 30 ± 3)
- Visit 3: Follow-up (Day 60 ± 3)
- Visit 4: End of Study (Day 90 ± 3) |
| Proportion of subjects who used rescue medication during the treatment period compared from baseline to the end of the study. |
- Visit 1: Screening/Baseline
- Visit 2: Follow-up (Day 30 ± 3)
- Visit 3: Follow-up (Day 60 ± 3)
- Visit 4: End of Study (Day 90 ± 3) |
| Incidence of Adverse Events and Serious Adverse Events throughout the trial duration, including clinically significant laboratory change(s) that occur during the study. |
- Visit 1: Screening/Baseline
- Visit 2: Follow-up (Day 30 ± 3)
- Visit 3: Follow-up (Day 60 ± 3)
- Visit 4: End of Study (Day 90 ± 3) |
| Change in the mean total scores of Food Frequency Questionnaire (FFQ) at the end of study visit 4 (Day 90 ± 3) compared to baseline. |
- Visit 1: Screening/Baseline
- Visit 2: Follow-up (Day 30 ± 3)
- Visit 3: Follow-up (Day 60 ± 3)
- Visit 4: End of Study (Day 90 ± 3) |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
Final Enrollment numbers achieved (Total)= "73"
Final Enrollment numbers achieved (India)="73" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/08/2025 |
| Date of Study Completion (India) |
09/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Current pharmacological treatments primarily provide palliative relief from symptoms without addressing the underlying cartilage disorder. Additionally, prolonged use of these treatments may lead to serious side effects, such as gastrointestinal problems, cardiovascular risks, and further cartilage damage. On the other hand, nutritional interventions provide a continuous strategy for managing and potentially preventing OA, serving as a valuable supplement to conventional OA treatments.12,13 The underlying cause of articular damage stems from an imbalance between anabolic and catabolic processes, which can be modulated by dietary compounds like nutraceuticals. Due to their minimal side effects, particularly over the long term, as well as their ease of extraction and low production Clinical Trial Protocol: CP-SMW001-25 Version 1.0, Dated: 26 Jun 2025 costs, nutraceuticals may offer a viable approach for the preventive management of osteoarthritis (OA).14 In recent years, there has been growing interest in nutraceutical supplements, which consist of a varied group of molecules with significant potential to reduce inflammation, oxidative stress, pain, and joint stiffness, while also promoting cartilage formation.13,15 Hence, this prospective, multicenter, open-label, single-arm study will evaluate the efficacy and safety of Smoothwalk tablets of Lee Health Domain (I) Pvt. Ltd. for the treatment of knee osteoarthritis.
Primary Objective • To evaluate the efficacy of Smoothwalk tablets in the treatment of patients with osteoarthritis and determine the Minimal Clinically Important Difference (MCID). Secondary Objective • To evaluate the impact of Smoothwalk tablets on the arthritis/joint pain intensity in patients with osteoarthritis. • To evaluate the safety of Smoothwalk tablets in the treatment of patients with osteoarthritis. Exploratory Objective • To evaluate the impact of Smoothwalk tablets on food intake in patients with osteoarthritis. |