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Clinical Trials/CTRI/2024/04/066319
CTRI/2024/04/066319CompletedPhase 2/3

A Randomized Comparative Clinical Trial to Assess the Effect of Sarshapa Yoga Lepa and Sarshapa Yoga Cream on Sheetpitta (Urticaria) wsr to Bhrajaka Pitta

NIA Jaipur1 site in 1 country40 target enrollmentStarted: June 4, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Changes in Urticaria Activity Score of Sheetpitta

Study Overview

Brief Summary

The demographic and clinical observations of the clinical trial were presented using detailed tables and bar diagrams. Statistical analyses were conducted separately for subjective and objective parameters. For intragroup comparisons, the Wilcoxon Signed-Rank Test was applied to subjective variables, while Paired t-Test was used for objective variables. For intergroup comparisons, the Mann–Whitney U Test was applied to subjective parameters, and the Unpaired t-Test was used for objective parameters.

The results revealed statistically significant improvements in Group B; however, the Sarshapa Yoga Cream group demonstrated superior efficacy compared to the Sarshapa Yoga Lepa group in reducing clinical symptoms. No adverse events were reported during the study period.

The chapter further provided a conceptual interpretation of the clinical findings, contextualizing them within Ayurvedic theoretical constructs. Probable mechanisms of action of the test formulation were discussed. Additionally, the limitations of the study were addressed, acknowledging factors that may have influenced the generalizability and scope of the results. This chapter comprised two major segments. The first segment provided a structured synopsis of the research work, summarizing its conceptual foundation, methodology, key observations, and principal findings. The second segment presented the final conclusions drawn from the study, along with future recommendations aimed at enhancing the scope, rigor, and applicability of subsequent research initiatives in this field.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subject between 18 to 40 year age group Subject with the classical feature of Sheetpitta Grade 1 to 3 of Urticaria Activity Score.

Exclusion Criteria

  • Person who are already diagnosed with other skin disorders like Eczema Psoriasis Subjects who are K/C/O Post Surgical Urticaria Giant Urticaria Subjects who are already diagnosed with complication of uncontrolled Diabetes Mellitus.

Outcomes

Primary Outcomes

Changes in Urticaria Activity Score of Sheetpitta

Time Frame: 1 month

Secondary Outcomes

  • Changes in Urticaria activity score of Sheetpitta(Changes in sign & symptoms of Sheetpitta (Kandu Mandala Saraga) & skin pH)

Investigators

Sponsor
NIA Jaipur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sangeeta Parihar

National Institute of Ayurveda Jaipur

Study Sites (1)

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