Health Condition 1: M259- Joint disorder, unspecified
Conditions
Interventions
None listed
Sponsors
Mittal Ayurved Sansthan
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of either sex 2.Age 18-65 years (both inclusive) 3.People who are suffering from muscle or joint pain. 4.Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events. 5.Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study. 6.Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the treatment areas during the treatment period. 7.If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 8.Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study. 9.Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
Exclusion criteria
Exclusion criteria: 1.Are pregnant, breast-feeding, or planning to become pregnant during the study. 2.Have participated in any other interventional clinical trial in the previous 30 days. 3.Severely traumatized and / or very severe mucosal inflammation. 4.Have open sores or open lesions in the treatment area(s). 5.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of Pain. 6.Have a known sensitivity to any of the constituents of the test product 7.Plan to seek alternative treatment of any kind for their Pain, in the eligible treatment areas or otherwise, during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Subject Global Assessment 2.Change in pain visual analog scale (VAS) scoresTimepoint: Any time-point from Baseline to Day 7 Any time-point from Baseline to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Western Ontario & McMaster Universities Pain Index (WOMAC) scores 2. Change in EQ-5D-5L Quality of life score Timepoint: Any time-point from Baseline to Day 7 Any time-point from Baseline to Day 7 | — |
Countries
India
Contacts
Public ContactPuneet Mittal
MGCTS(Mittal Global Clinical Trial Services)
Outcome results
None listed