| CTRI Number |
CTRI/2025/07/090590 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to evaluate use of khadiradi kadha orally and khadiradi ointment loacaly on skin disease |
|
Scientific Title of Study
|
Randomised Comparative Three Arm clinical
study to evaluate the efficacy of Khadiradi Kashay
orally, Khadiradi Raskriya Topically and Both
combined together in Ekakushtha wsr to Psoriasis |
| 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 Rushikesh Patil |
| Designation |
PG Scholar |
| Affiliation |
Aarogyashala Rugnalaya |
| Address |
OPD no 13 Aarogyashala Rugnalaya Panchavati Nashik
OPD no 13 Aarogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9049704817 |
| Fax |
|
| Email |
rushisp565@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Garge |
| Designation |
MD Kaychikitsa |
| Affiliation |
Aarogyashala Rugnalaya |
| Address |
Aarogyashala Rugnalaya Panchavati Nashik
OPD no 13 Aarogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405366160 |
| Fax |
|
| Email |
drhgarge@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rushikesh Patil |
| Designation |
PG Scholar |
| Affiliation |
Aarogyashala Rugnalaya |
| Address |
OPD no 13 Aarogyashala Rugnalaya Panchavati Nashik
OPD no 13 Aarogyashala Rugnalaya Panchavati Nashik
MAHARASHTRA
422003
India |
| Phone |
9049704817 |
| Fax |
|
| Email |
rushisp565@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rushikesh Patil |
| Address |
Aarogyashala Rugnalaya Ganeshwadi Panchavati Nashik
422003 |
| 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 Rushikesh patil |
Arogyashala Rugnalaya |
OPD no 13 Aarogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA |
9049704817
rushisp565@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Ayurved Seva Sangh Ayurved mahavidyalaya, Nashik |
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: TVAGGATAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: khadiradi kashya, Reference: charak chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: group 2 is given khadiradi rasakriya for topical application | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: khadiradi kashya, Reference: Charak chikitsa sthan, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Along with Khadiradi raskriya, Reference: Charak chikitsa sthan, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: khadiradi rasakriya, Reference: Charak chikitsa sthan, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group: - 18 to 60 years.
2) Patients with clinical features of EKA-KUSHTA having signs and
symptoms namely Kandu (itching), Shushkta, Vaivarnya
(Depigmentation),Mastyashakloptama (silvery patchy skin).
3) Patients of both Gender.
13
4) Patient who is willing to participate and in written provide in
inform consent will be entertain in study. |
|
| ExclusionCriteria |
| Details |
1) Patient suffering from any chronic skin disease, immune suppressed
systemic disorders.
2) Patient suffering from any other systemic disorders like
tuberculosis, diabetes melitus, HBsAg positive patients and
known case of leprosy.
3) Pregnant & Lactating woman.
4) Psoriatic arthritis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of khadiradi Raskriya topically
using PASI score in ekakustha. ( psoriasis )
2. To study the efficacy of khadiradi kashaya orally using PASI
score in ekakustha. . ( psoriasis )
|
9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of khadiradi Raskriya topically with khadiradi
kashaya orally in signs & symptoms of ekakustha.
|
9 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Certainly exploring various treatment modalities for Ekakushta (psoriasis) is crucial especially considering its tendency for relapse in many patients Research into different approaches can lead to better management and potentially more effective long-term outcomes Ayurveda offers a holistic approach to treating psoriasis focusing on balancing the bodys energies and promoting overall wellbeing Many people find relief and long-term benefits from Ayurvedic treatments for psoriasis In modern medicine there is only antifungal and steroid treatment PUVA therapy which gives serious side effects like hepatic nephrotoxixity bone marrow depression,but recurrence is very common Hence its is the need to find out safe and effective treatment for psoriasis and here ayurveda plays an importance role treatment modality of ayuveda provided long lasting results and better life to patient Skin is very essential organ for cosmetic purpose Person look is the main factor of the personality In the patient of psoriasis the mental health of the mind is disturbed due to his look So for the cosmetic purpose I selected khadiradi rasakriya for topically use which is easily available and affordable for patients So we have decided to study |