Skip to main content
Clinical Trials/CTRI/2019/12/022529
CTRI/2019/12/022529Not yet recruitingPhase 2

A Comparative Clinical Study on Effect of Shweta Chandanadi Lepa and Kinsukadi Tailam In Twak pratyurjata W.S.R to Cosmetic Induced Skin Allergy

National Institute of Ayurveda1 site in 1 country45 target enrollmentStarted: January 1, 2020Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
45
Locations
1
Primary Endpoint
Skin Allergy

Study Overview

Brief Summary

The study is a Randomized comparative clinical and open-label study to compare the effect of the Shweta chandanadi lep and s Kinshukadi Tailam in cosmetic induce skin allergy.

Grouping for Clinical Study**:** 90 clinically diagnosed and registered patient of Cosmetic induced skin allergy will be divided randomly into two groups. Each group will have 45 patients.

                        GROUP A**:** 45 clinically diagnosed and registered patient of skinallergy will be treated by local application of Shweta chandanadi lepa and internal use of Manjisthadi kwath

Duration – 2 month

Dose –    1.    Lepa once daily for 2 month with honey

2*.*40 ml  Kwath twice daily

GROUP B: 45 clinically diagnosed and registered patient of skin allergy will be treated  by local application of Kinshukadi Tailam and internal use of Manjisthadi kwath

Duration –      2   month

Dose – 1.       40 ml/ week oil for external application

  1.       40 ml Kwath twice daily

FOLLOW UP

Follow up of the patients will be taken at every 15 days interval for 60 days i.e. 1st day, 15 days, 30 days, 45 days and 60 days of study.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.All patients having complaint skin allergy due to use of any cosmetics and of clinical features like redness itching, urticaria, rashes will be selected for this clinical trial.
  • 2.Patients of age group 20-70 years of either gender visiting the OPD and willing to provide written, informed consent will be selected to the study on basis of specially prepared Performa including relevant parameters.
  • 3.Patients will be selected randomly, irrespective of gender, economical, educational and marital status.
  • 4.Patient ready to give written informed consent.

Exclusion Criteria

  • ➢Patients not ready to give an informed consent.
  • ➢Patients who have been diagnosed to have local disease like burn, psoriasis leucoderma, leprosy, herpes, measles.
  • ➢Patients suffering from any kind of Malignancy, Diabetes, Cardiac disorder, HIV etc.
  • ➢Patients who are on steroids or there is history of prolonged steroid use or chemo-therapeutic agents.

Outcomes

Primary Outcomes

Skin Allergy

Time Frame: 3 Month ,15 day

Secondary Outcomes

  • Contact dermatitis(6 Month)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

Loading locations...

Similar Trials