CTRI/2023/10/058518
Not yet recruiting
Phase 4
An Open Label, single Arm Clinical Study to evaluate the safety and efficacy of Nara-N Pain oil in patients having Muscular pain - NI
Mittal Ayurved Sansthan0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M259- Joint disorder, unspecified
- Sponsor
- Mittal Ayurved Sansthan
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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