| CTRI Number |
CTRI/2024/10/075404 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of local application of Prapunnatadi Lepa and Khadirvrushadi Lepa in Dadru kushtha (Tinea corporis). |
|
Scientific Title of Study
|
Open randomized comparative clinical study of local application of Prapunnatadi Lepa with Khadirvrushadi Lepa in management of Dadru with special reference to Tinea Corporis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Yashwant Nalawade |
| Designation |
post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
department of kayachikitsa 2nd floor APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9960771195 |
| Fax |
|
| Email |
nalawadeaishwarya.20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anaya Pathrikar |
| Designation |
Professor and HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Kayachikitsa 4th floor APMs Ayurved Mahavidyalaya sion near sion railway station Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anaya Pathrikar |
| Designation |
Professor and HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Kayachikitsa 4th floor APMs Ayurved Mahavidyalaya sion near sion railway station Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvidya Prasarak Mandal APMs Ayurved mahavidyalaya near sion railway station sion mumbai India 400022 |
|
|
Primary Sponsor
|
| Name |
Aishwarya Yashwant Nalawade |
| Address |
APMs Ayurved Mahavidyalaya Sion near sion Railway station Sion MUmbai 400022 |
| 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 Aishwarya Yashwant Nalawade |
APMs Ayurved Mahavidyalaya and seth R V Ayurved Hospital Sion Mumbai |
Department of kayachikitsa 2nd floor APMs Ayurved Mahavidyalaya Sion near sion railway station Sion Mumbai 400022
Mumbai
MAHARASHTRA |
9960771195
nalawadeaishwarya.20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar samhita uttarkhanda 11/50, Procedure details: All the drugs of Lepa churna are taken in same amount
& then will be mixed with Takra to gain desirable consitency .This lepa then will be applied on lesions of Dadru )
(1) Medicine Name: Prapunnatadi lepa, Reference: Sharangdhar samhita uttarkhanda 11/50, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Ashtang Hridaya chikitsasthan 19/91, Procedure details: All the drugs of lepa churna are taken in same amount & then it will be mixed with Gomutra to attain the desirable consistency & then Lepa will be applied on lesions of Dadru.)
(1) Medicine Name: Khadirvrushadi lepa, Reference: Ashtang Hridaya chikitsasthan 19/91, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Age-18 to 80 years.
2. Sex – All genders
3. Patient with signs and symptoms of Dadru like Kandu, Pidika, Vaivarnya
and mandala.
4. Understanding and willing to sign the informed consent form.
5. Area of lesion up to 25cm 2 |
|
| ExclusionCriteria |
| Details |
1. Patient having skin lesion other than Dadru kushtha (Tinea corporis) like Eczema, psoriasis, urticaria
etc.
2. Pregnancy and lactating mother.
3. K/C/O AIDS (HIV +ve), HbSAg +ve etc. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
size of lesion
number of lesion (in specific area of body) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The symptoms of Dadru mentioned in text and practically observed will be assessed at each follow-up.
Kandu (Itching), Raga (Erythema), Pidaka (papule), Daha (burning). |
15 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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 |
|
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
|
In slum areas people treat fungal infections only in monsoon. To treat the infections, they use
antifungal creams. There are certain antifungal creams that contain steroids. Long term use of such
creams causes resistance to the dermatophytes, causing Lichenification, Hyperkeratosis and Hypertrophy
of localized skin.
According to Ayurveda, Dadru being a Twakgat vyadhi, out of all the treatment modalities, Lepa
is one of the best types of local application and the most effective method of drug administration for
treating skin conditions, as it penetrates the deeper layers of skin. It is also readily available and
reasonably priced.
I therefore made the decision to research the impact of local applications of ‘Prapunnatadi Lepa’
and ‘Khadirvrushadi Lepa’ in Dadru with a focus on Tinea Corporis. There are several Ayurvedic preparations for treating Dadru that can be used both internally and
externally. It is necessary to study and evaluate efficacy of these medications by scientific research.
As all the contents of Prapunnatadi Lepa are herbal in nature, they are cost effective and easily
available, proving beneficial to the society. Considering their ayurvedic properties they might even prove
useful in certain contagious skin diseases. |