A Multicentric, Randomized, Double Blind, Three-Arm, Comparative Clinical Study to Evaluate the Safety and Efficacy of HSSH-062501 in Participants with Mild to Moderate Chronic Joint Pain
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- •Pain at rest and motion
研究概览
简要总结
Efficacy Study Summary
This clinical study evaluates the safety and efficacy of HSSH 062501 in participants with mild to moderate chronic joint pain. It is a multicentric, randomized, double blind, three-arm interventional study sponsored by Himalaya Wellness Company, Bengaluru. The study includes 300 participants divided into three groups receiving HSSH 062501, Marketed Shallaki, or Diclofenac followed by placebo over 28 days. An open-label safety extension study will follow for 56 days with 40 participants continuing on HSSH 062501.
Title: A Multicentric, Randomized, Double Blind, Three-Arm, Comparative Clinical Study to Evaluate the Safety and Efficacy of HSSH-062501 in Participants with Mild to Moderate Chronic Joint Pain
Objectives: Evaluate safety and efficacy of HSSH 062501
Sponsor: Himalaya Wellness Company, Bengaluru
Type: Interventional
Participants: 300 (100 per arm)
Duration: 28 days
Arms:
· HSSH 062501 (600 mg)
· Marketed Shallaki (600 mg)
· Diclofenac (75 mg for 7 days) followed by placebo
Indication: Chronic musculoskeletal conditions including osteoarthritis, rheumatoid arthritis, gout, spondylosis, frozen shoulder, tennis elbow
Visits: Baseline, Day 7, Day 28
Endpoints: Pain reduction, symptom improvement, quality of life, rescue medication use, GI tolerability, adverse events
Extended Safety Study Summary
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Title:An open-label Clinical Study to Evaluate the Safety and Tolerability of HSSH-062501 in Participants with Mild to Moderate Chronic Joint Pain.
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Participants: 40 (from efficacy study)
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Duration: 56 days
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Product: HSSH 062501 (600 mg)
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Visits: Baseline (based on previous EOS data), Day 56
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Objectives: Assess long-term safety and tolerability
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Endpoints: GI tolerability, adverse events
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Assessments: Physical exam, vitals, lab tests, GSRS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 to below 65 years.
- •2.Diagnosed with one of the following conditions with mild to moderate pain: Osteoarthritis Rheumatoid arthritis Gout Spondylosis Other chronic joint pain (e.g., Frozen Shoulder, Tennis Elbow) 3.Pain score between 1 to 6 on the Numerical Rating Scale (NRS).
- •(Only the most painful site will be considered if multiple sites are involved.) 4.No use of other medicines or supplements for the condition 10 days before screening and during the study.
- •5.Women of childbearing age and men with such partners must use effective birth control during the study.
- •6.Men must not donate sperm from the start of the study until 90 days after it ends.
- •7.Not part of any other clinical study in the last 3 months.
- •8.Willing to sign informed consent and follow study procedure.
排除标准
- •1.Severe joint pain or recent injury causing immobility 2.Requires injections, surgery, or hospitalization 3.Severe back pain with disc or nerve issues such as sciatica 4.History of joint replacement or mobility-limiting hip or back pain 5.Use of steroids, DMARDs, or joint injections in the past six months 6.Physical disability affecting study assessments 7.History of gastrointestinal bleeding, ulcers, or perforation 8.Active gastrointestinal issues such as GERD or gastritis with GSRS score greater than one 9.Major health conditions such as heart, liver, neurological, or congenital disorders 10.Participants with HbA1c levels equal to or greater than eight percent, indicating uncontrolled diabetes, will be excluded from the study 11.Drug abuse or inability to follow study instructions 12.Pregnant or breastfeeding women 13.Allergy to study product ingredients 14.Any condition affecting study compliance as determined by the investigator.
结局指标
主要结局
•Pain at rest and motion
时间窗: Day 0, Day 7, & Day 28
•Tenderness and swelling (not for spondylosis)
时间窗: Day 0, Day 7, & Day 28
•Quality of life improvement
时间窗: Day 0, Day 7, & Day 28
•Rescue medication usage
时间窗: Day 0, Day 7, & Day 28
Rheumatoid Arthritis
时间窗: Day 0, Day 7, & Day 28
•Morning stiffness duration
时间窗: Day 0, Day 7, & Day 28
•Grip strength
时间窗: Day 0, Day 7, & Day 28
•Tender joint count
时间窗: Day 0, Day 7, & Day 28
Osteoarthritis
时间窗: Day 0, Day 7, & Day 28
•Chair stand test
时间窗: Day 0, Day 7, & Day 28
•Stair climb test
时间窗: Day 0, Day 7, & Day 28
•Fast-paced walk test
时间窗: Day 0, Day 7, & Day 28
•Range of motion (also for spondylosis)
时间窗: Day 0, Day 7, & Day 28
All Participants
时间窗: Day 0, Day 7, & Day 28
•Change in 24-hour Average pain intensity (Baseline24hr-EOS24hr) through NRS.
时间窗: Day 0, Day 7, & Day 28
•Participants with 50 percent or more improvement
时间窗: Day 0, Day 7, & Day 28
次要结局
- Efficacy study:(•Assessment of GI (Gastrointestinal) tolerability)
- Extended Safety Study:(•GI (Gastrointestinal) tolerability throughout the study.)
研究者
Dr Bharath Raj R
Mithra Multispeciality Hospital