A clinical trial to study the effect of an Ayurvedic Formulation in patients with musculoskeletal pains
- Conditions
- Health Condition 1: null- Musculoskeletal Pains
- Registration Number
- CTRI/2012/05/002647
- Lead Sponsor
- uZen Herbal Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â??At least 50% improvement on the VAS (Visual analogous score) pain from Baseline visit to after Visit 2 & Visit 3 of treatmentTimepoint: Screening,Baseline,Day 10,End of the treatment
- Secondary Outcome Measures
Name Time Method â??Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drugTimepoint: Screening,Baseline,Day 10,End of the treatment