A Single Centre, Prospective, Open labeled Study to Evaluate Safety & Efficacy of NHPL/OZ-01 an Ayurvedic Formulation in patients with Musculoskeletal Pains
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- –At least 50% improvement on the VAS (Visual analogous score) pain from Baseline visit to after Visit 2 & Visit 3 of treatment
研究概览
简要总结
This study is an open labeled, single centre, Prospective trial to evaluate the Safety & Efficacy of NHPL/OZ-01 Ayurvedic formulation {Composition: Each 50 ml of syrup contains extracts derived from - 1) Haridra (Curcuma longa rhizome) 1gram 2) Pippali (Piper longum fruit) 500 mg 3) Vanya ashwagola (Plantago lanceolata leaves) 1 gram 4) Sthula ela (Amomum subulatum fruit & seeds) 1 gram 5) Kaalmegh (Andrographis paniculata whole plant) 1 gram 6) Tvak (Cinnamomum zeylanicum stem bark) 250 mg 7) Bhutruna (Andropogan citrates leaves) 250 mg} in the treatment of patients with musculoskeletal pains
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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.Subjects of either sex 2.Age above 18 years 3.Willing to give written consent 4.Subjects suffering from Musculoskeletal pains: Myalgia, Neck pain, limb pain, low back pains, Joint Pains, Stiffness and Wide spread musculoskeletal pains.
- •5.Pain score of at least 4 cm on a 10-cm linear visual analogue scale.
排除标准
- •1Contraindications or Hypersensitivity to the active substances or to any of the excipients of the drug.
- •2Subjects currently on any other NSAID therapy.
- •3History or presence of any medical condition or disease according to the discretion of the Investigator.
- •4History of significant renal or hepatic problems / abnormal functions.
- •5History of significant asthma, urticaria or other allergic reactions 6History of significant gastric and/or duodenal ulceration such as Mal-absorption syndrome.
- •7History of diabetes, coronary artery disease and hypertension with or without complication 8History of any chronic physical, hormonal, immune or psychiatric illness 9Currently taking any herbal preparations 10Individuals refusing to use appropriate non-hormonal birth control measures.
- •11Subjects participating in any other trial.
- •12Female subjects found positive in urine pregnancy test.
- •13Lactating Mothers 14Subjects not willing to comply with protocol requirements.
结局指标
主要结局
–At least 50% improvement on the VAS (Visual analogous score) pain from Baseline visit to after Visit 2 & Visit 3 of treatment
时间窗: Screening,Baseline,Day 10,End of the treatment
次要结局
- –Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug(Screening,Baseline,Day 10,End of the treatment)