| CTRI Number |
CTRI/2025/07/091647 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [other than classical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on the effectiveness of zandu senior joint care tablet for relieving joint & muscle pain in adults with Osteoarthritis. |
|
Scientific Title of Study
|
An Open label, Single Arm Interventional Study to Assess the Efficacy of Zandu Senior Joint Care Tablet in Adult Subjects for the management of Musculoskeletal joint pain & inflammation associated with osteoarthritis” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PLC0131125EL Version V02 R0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayan Balakrishnan |
| Designation |
Professor - Department of Orthopaedics |
| Affiliation |
Saveetha Medical College and Hospital SIMATS |
| Address |
Department of Orthopaedics 2nd Floor Hospital building clinical research facility room 01 Saveetha MedicalCollege and Hospital SIMATS Thandalam Chennai India
Chennai
TAMIL NADU
602105
India |
| Phone |
9884587223 |
| Fax |
|
| Email |
docvijayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayan Balakrishnan |
| Designation |
Professor - Department of Orthopaedics |
| Affiliation |
Saveetha Medical College and Hospital SIMATS |
| Address |
Department of Orthopaedics 2nd Floor Hospital building clinical research facility room 01 Saveetha MedicalCollege and Hospital SIMATS Thandalam Chennai India
Chennai
TAMIL NADU
602105
India |
| Phone |
9884587223 |
| Fax |
|
| Email |
docvijayan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogendra Kumar Choudhary |
| Designation |
Director & CEO |
| Affiliation |
Prothix Lifesciences Pvt Ltd |
| Address |
Prothix Lifesciences Pvt Ltd 2nd Floor Regus B-Block Shriram Business Park Vidhan Sabha Road Mowa
Raipur
CHHATTISGARH
492001
India |
| Phone |
09039340075 |
| Fax |
|
| Email |
ceo@prothixlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Emami Ltd Emami Tower 687 Anandapur E.M. Bypass Kolkata 700107 India |
|
|
Primary Sponsor
|
| Name |
Emami Ltd |
| Address |
Emami Ltd Emami Tower 687 Anandapur E.M. Bypass Kolkata 700107 India |
| Type of Sponsor |
Other [FMCG - Personal care & Health care company] |
|
|
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 Vijayan Balakrishnan |
Saveetha Medical College and Hospital SIMATS |
Department of Orthopaedics, 2nd Floor, Hospitalbulding clinical research facility room 01, SaveethaMedical College and Hospital SIMATS
Chennai
TAMIL NADU |
9884587223
docvijayan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha MedicalCollege and HospitalInstitutional EthicsCommittee |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zandu Senior Joint Care Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 550(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult Participants, Male or female between 30-65 years of age
2.Participants with a score of 4 or more on the Visual Analogue Score (VAS)
3.Participants with Osteoarthritis Index(WOMAC) more than 0
4.Participants with symptoms consistent with generalized pain or OA for at least six months prior to screening.
5. Participants who are continuing any NSAIDS or other analgesic medication taken for any other condition including current generalized pain.
6.Participants with non-significant safety profile of blood (CBC, Liver and Kidney)
7.Participants with a documented history of musculoskeletal pain and inflammation, consistent with generalized pain and/or osteoarthritis, persisting for a duration of 6 months or more prior to screening The condition should be stable, not requiring hospitalization, and classified as chronic musculoskeletal pain.
8.Participants willing to give voluntary informed consent
4.Participants with symptoms consistent with generalized pain or OA for at least six months prior to screening.
5. Participants who are continuing any NSAIDS or other analgesic medication taken for any other condition including current generalized pain.
6.Participants with non-significant safety profile of blood (CBC, Liver and Kidney)
7.Participants with a documented history of musculoskeletal pain and inflammation, consistent with generalized pain and/or osteoarthritis, persisting for a duration of 6 months or more prior to screening The condition should be stable, not requiring hospitalization, and classified as chronic musculoskeletal pain.
8.Participants willing to give voluntary informed consent
|
|
| ExclusionCriteria |
| Details |
1.Participants with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management. painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. Subjects with Grade 2 & 3 sprain or strain.
2.Participants having history of Blood and lymphatic system disorder, cardiac disorder apart from hypertension, congenital familial and genetic disorder, immune system disorder, neoplasms benign, malignant and unspecified disorder, psychiatric disorder, Renal, urinary disorder and autoimmune diseases an active infectious disease (HBV, HCV, HIV) which in the opinion of the investigator would influence the conduct and outcomes of the study.
3.Participants with any other type of arthritis other than osteoarthritis (eg – rheumatoid arthritis, gouty arthritis, psoriatic arthritis, etc.)
4.Participants with uncontrolled hypertension (Diastolic bloodHJ pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
5.Use of any oral or topical analgesic, antipyretic, sedative, anti-inflammatory, muscle relaxants or any other oral or topical medications which in the opinion of the investigator would influence the conduct and outcomes of the study.
6.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation.
7.Any kind of neuralgic pain, headache and/or chronic pain.
8.Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
9.A known pregnancy or lactation
10.Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding or Scheduled elective surgery or other invasive procedures during the period of study participation.
11. Participants who are severe smokers and drinkers.
12.Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication.
13.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.
14. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Sponsor physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change from Baseline in Visual Analogue Scale (VAS) For Assessment of Generalized Pain to end of the treatment and Follow-up visit
2.Change from Baseline in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): [scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely] to end of the treatment and Follow-up visit |
Timeframe - Baseline, Day - 15, Day - 30, Day - 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from Baseline in inflammatory Biomarker (ESR & CRP) to end of the treatment
Monitoring and recording of all adverse events (AEs) and serious adverse events
Assessment of long-term effects and recovery progress of osteoarthritis treatment
Change from Baseline in Kellgren-Lawrence classification system |
Time frame - Baseline, Day-15 Day-30, Day-45 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/08/2025 |
| 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="8"
Days="10" |
|
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 potential participants who are willing to provide a written informed consent form will be asked to come for screening. The main inclusion criteria of the screening procedure will be VAS score of 4 or above and WOMAC > 0.. The subjects will be asked specific history of having Acute Musculoskeletal Pain e.g. musculoskeletal injuries (pain & inflammation) consistent with generalized pain and OA for at least 6 months prior to screening and not requiring admittance to hospital. its severity. Any underlying condition which will affect the current pain or evaluation of treatment will be sought for and excluded by history and physical examination. The participants will then beallocated to receive oral treatment of (IP) Zandu Senior Joint Care Tablet. for 30 days and on the day of scheduled visits (day1, day 15 and day 30). Post dose follow-up visit after 15 days i.e on day 45th the evaluation of quality of pain along with safety assessment will be executed. A subject will remain on study till 45 days. Subjects who discontinue (IP) Zandu Senior Joint Care Tablet before 30 days will be followed for 15 days after the last dose of (IP) Zandu Senior Joint Care Tablet and then complete the end-of-study visit. The clinical site team will evaluate the safety data throughout the study, including an initial safety review after the first 15 subjects have received at least 1 oral dose of (IP) Zandu Senior Joint Care Tablet.
|