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Clinical Trials/CTRI/2023/10/058518
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Pms

Investigators

Sponsor
Mittal Ayurved Sansthan

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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