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”
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Emami Ltd
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 1.Change from Baseline in Visual Analogue Scale (VAS) For Assessment of Generalized Pain to end of the treatment and Follow-up visit
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •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.
- •8.Participants willing to give voluntary informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.Change from Baseline in Visual Analogue Scale (VAS) For Assessment of Generalized Pain to end of the treatment and Follow-up visit
Time Frame: Timeframe - Baseline, Day - 15, Day - 30, Day - 45
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
Time Frame: Timeframe - Baseline, Day - 15, Day - 30, Day - 45
Secondary Outcomes
- 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)
Investigators
Dr Vijayan Balakrishnan
Saveetha Medical College and Hospital SIMATS