| CTRI Number |
CTRI/2025/08/092267 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Comparing with other drug] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PANCH SHIRISH AGAD AND EDGAJADI LEPA IN DADRU KUSHTHA WITH SPECIAL REFERENCE TO FUNGAL INFECTION. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savita popandiya |
| Designation |
PG Scholar |
| Affiliation |
R.A. Podar medical (ayu) college worli, mumbai-18 |
| Address |
Opd No.15 Agadtantra Department
M.A.Podar hospital, R.A.Podar medical(ayu) college worli Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7024515590 |
| Fax |
|
| Email |
savitadhakad12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhashini lahankar |
| Designation |
Hod & professor |
| Affiliation |
R.A. Podar medical (ayu) college worli, mumbai-18 |
| Address |
Opd No.15 Agadtantra Department
M.A.Podar hospital, R.A.Podar medical(ayu) college worli Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9833173571 |
| Fax |
|
| Email |
drslahankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savita popandiya |
| Designation |
PG Scholar |
| Affiliation |
R.A. Podar medical (ayu) college worli, mumbai-18 |
| Address |
Opd No.15 Agadtantra Department
M.A.Podar hospital, R.A.Podar medical(ayu) college worli Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7024515590 |
| Fax |
|
| Email |
savitadhakad12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd no.15, Agadtantra Department, M.A. Podar hospital, R. A. Podar govt(ayu) college, worli, mumbai 400018 Maharashtra. |
|
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Primary Sponsor
|
| Name |
R A Podar Govt Ayu collage worli mumbai |
| Address |
R.A.Podar medical(ayu) college worli mumbai-18, Dr annie besant road, pincode 400018 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Savita popandiya |
Mahadevi Anandilal Podar Govt. Hospital |
OPD NO.15, Agadtantra Department, R.A.Podar Govt(Ayu) Medical college, worli,
Dr annie besant road,
Pincode-400018
Mumbai,
Mumbai
MAHARASHTRA |
7024515590
savitadhakad12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committee of institution, R.A. Podar govt ayu college, worli |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: DADRU-KUSHTHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Edgajadi lepa, Reference: Charak chikitsa 7/126, Route: Topical, Dosage Form: Lepa Churna, Dose: 200(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchshirish agad, Reference: Charak chikitsa 23/218, Route: Topical, Dosage Form: Lepa Churna, Dose: 200(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Pacient with sign and symptoms of Dadru like kandu, Pidika, Vaivarnya and Mandala.
Understanding and being willing to sign the Consent form. |
|
| ExclusionCriteria |
| Details |
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. |
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To study the role of Panchshirish agad and Edgajadi lepa in reducing kandu, vaivarnya in Dadru kushtha.
To study the role of Panchshirish agad and Edgajadi lepa in reducing the area of lesion in Dadru Kushtha. |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
1 month |
| To access the possible mode of action of arka tail. |
1 month |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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.
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