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Clinical Trials/CTRI/2025/08/092267
CTRI/2025/08/092267Not yet recruitingPhase 3

AN OPEN RANDOMISED CONTROLLED CLINICAL STUDY TO COMPARE AND EVALUATE THE EFFICACY OF PANCHSHIRISH AGAD AND EDGAJADI LEPA IN DADRU KUSHTHA WITH SPECIAL REFERENCE TO FUNGAL INFECTION.

R A Podar Govt Ayu collage worli mumbai1 site in 1 country80 target enrollmentStarted: August 15, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
To study the role of Panchshirish agad and Edgajadi lepa in reducing kandu, vaivarnya in Dadru kushtha.

Study Overview

Brief Summary

Introduction                                                                                                       Skin is the first line of defence for internal organs and also performs other essential function such as regulation and sensation. Skin has been described as a mirror of body as it reflects the physical, mental and psychological state of individuals. In the era of modernization there has been a considerable increase in the incidence of Skin diseases due to changing lifestyle, stress, improper food habits, unhygienic condition, frequently use of various antibiotics. Skin disease create an emotional concern for an individual which includes embarrassment, anxiety, depression and shame. In Ayurveda kushtha is a broad term which covers almost all skin disorders. Viruddha ahaar-vihar sevan, Vegvidharana, Divaswapn etc. are the hetu of kushtha.

There are 18 types of kushtha roga. Dadru is attributed to be one of the kshudra kushtha and is generally referred as Fungal infection in modern view. Kushtha are caused by Tridoshdushti alog with twak, Rakta, Mansa, and Ambu. Kushtha is included in Santarpanjanya Vyadhi and Raktadushtikar Vyadhi. However Dadru is also identified with dominance of pitta kapha dosha.

Fungal skin infections commonly affect the outer layer of skin, nails and hair. Most of the fungi causing infections are usually dermetophytes (tinea), yeast (candida) and molds. Most of the times, fungal skin infections may appear red, scaly and itchy. The rashes present have a well-defined border and sometimes it appear like a dry skin.

Need of study

According to Acharya charak, out of six layer of twacha, Dadru is the vyadhi of chaturth twacha. Lepa is one of the best route of administration in skin diseases as it is easily available and affordable. So I have decided to see the effect of local application of ’panch shirish agad lepa versus ’Edgajadi lepa’ in Dadru with special reference to ’Fungal infection’

No of patients

Group A - study group - 40 patients will apply ’Panch shirish agad lepa’

Group B - study group - 40 patients will apply ’Edgajadi lepa’

Investigations

CBC, BSL, LFT, RFT, HBsAg

Summy and Conclusion

The work will be summarised to make final conclusions. Observation of result will be concluded with statistical analysis. Conclusion with explanation will be summarised at the end of whole research. The data collected from CRF will be subjected to statistical analysis, appropriate

Statistical test will be applied to the data generated and significance of improvement will be studied.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Pacient with sign and symptoms of Dadru like kandu, Pidika, Vaivarnya and Mandala.
  • Understanding and being willing to sign the Consent form.

Exclusion Criteria

  • 1.Patient having Skin lesion other than Dadru Kushtha( tinea infection) like Eczema,Psoriasis, Urticaria, etc.
  • 2.Patient having Immuno-compromised disease and medication.
  • 3.Patient having uncontrolled Diabetes Mellitus.

Outcomes

Primary Outcomes

To study the role of Panchshirish agad and Edgajadi lepa in reducing kandu, vaivarnya in Dadru kushtha.

Time Frame: 4 week

To study the role of Panchshirish agad and Edgajadi lepa in reducing the area of lesion in Dadru Kushtha.

Time Frame: 4 week

Secondary Outcomes

  • 1.To access the possible mode of action of Panchshirish agad.(2.To see the comparative result of Panchshirish agad and Edgajadi lepa in Dadru kushtha.)
  • To access the possible mode of action of arka tail.(1 month)

Investigators

Sponsor
R A Podar Govt Ayu collage worli mumbai
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Savita popandiya

R.A. Podar medical (ayu) college worli, mumbai-18

Study Sites (1)

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