| CTRI Number |
CTRI/2024/07/071233 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Single arm study to see the effect of prapunnadadi lepa in dadru kushta |
|
Scientific Title of Study
|
Single arm clinical study to assess the efficacy of Prapunnadadi Lepa in the management of Dadru Kushta. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amruta Ramesh Rajmane |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department, LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9130445542 |
| Fax |
|
| Email |
abhirajmaneamr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHINANDAN PATIL |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department, LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Ramesh Rajmane |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department, LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9130445542 |
| Fax |
|
| Email |
abhirajmaneamr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete rajarambapu ayurvedic medical college hospital post graduate institute and research centre Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Amruta Ramesh Rajmane |
| Address |
Loknete rajarambapu ayurvedic medical college hospital post graduate institute and research centre Islampur 415409 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amruta Ramesh Rajmane |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur |
LRP ayurvedic medical college hospital post graduate institute and research centre Islampur 415409 OPD no 1 Kayachikitsa
Sangli
MAHARASHTRA |
9130445542
abhirajmaneamr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prapunnadadi Lepa, Reference: Sharangdhara Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients diagnosed as Dadru Kushta as per sign and symptoms which are mention in Ayurvedic Samhita.
2)Gender-Irrespective of gender and socioeconomic status.
3)Age-Above 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
1)Pregnant women and lactating women.
2)Less than 18 years and more than 60 years.
3)Mandal with secondary infection & immuno suppressive.
4)Mandal more than 7 in number.
5)Mandal measuring above 10 cm in length and above 10 cm in breadth. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the effect of Prapunnadadi Lepa in the management of Dadru Kushta. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study Dadru Kushta in Ayurvedic perspective.
2)To study Prapunnadadi Lepa in detail in Dadru Kushta.
3)To study the efficacy of Prapunnadadi Lepa in Dadru Kushta. |
10 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/08/2024 |
| 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 |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dadru Kushta is explained under the heading Kshudra Kushta
by Acharya Charaka and Mahakhushtha by Acharya Sushruta. Skin is the largest organ of human body. Its size and
external location makes it susceptible to a wide variety of disorder. All the
skin diseases in Ayurveda have been classified under the broad heading of
Kushta which are further categorized into Mahakushta and Kshudra Kushtas. Dadru Kushta is one of among Kushta rogas which is caused by
Virudhashan, Vishmashan, Kledakar aahar. Over indugence in Nidan, Tridoshas
leads to vitiation of Vata while vitiated Pitta and Kapha through Tiryakgami
siras, Twak,Mansa, Rakt, Ambu dusthi causes Dadru Kushta |