| CTRI Number |
CTRI/2023/11/060060 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/11/2023 |
| 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 Ayurvedic Decoction in skin disease |
|
Scientific Title of Study
|
A Controlled Phase II Clinical study to Evaluate the Efficacy of Trivrittadi kashaya as Virechan Kalpa in Dadru Kushtha 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 |
Dr Snehal Yashawnt Sarwate |
| Designation |
PG student |
| Affiliation |
Ayurved Seva Sangha Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 24 Panchakarma OPD
Nashik
MAHARASHTRA
416520
India |
| Phone |
8698054604 |
| Fax |
|
| Email |
snehalsarwate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Kulkarni |
| Designation |
PG Guide |
| Affiliation |
Ayurved Seva Sangh Arogyashala Rugnalaya, Nashik |
| Address |
OPD no 24 Panchakarma OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423081487 |
| Fax |
|
| Email |
drsavita.k07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Kulkarni |
| Designation |
PG Guide |
| Affiliation |
Ayurved Seva Sangh Arogyashala Rugnalaya, Nashik |
| Address |
OPD no 24 Panchakarma OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423081487 |
| Fax |
|
| Email |
drsavita.k07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Yashawnt Sarwate |
| Address |
A.S.S. Arogyashala Rugnalaya Ganeshwadi, Panchavati, Nashik |
| 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 Snehal Sarwate |
Arogyashala Rugnalay Nashik |
OPD no 24 Panchakarma OPD
Nashik
MAHARASHTRA |
8698054604
snehalsarwate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KUSHTHAM, (3) 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: Trivrittadi Kashaya, Reference: Charak Samhita Kushtha Chikitsa adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Trivrittadi Kashaya, Reference: Charak Samhita Kushtha Chikitsa adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trivritta Avaleha , Reference: Ashtanga Hridaya Virechan Kalpa adhyaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: Virechan Kalpa |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with any of classical signs and symptoms of Dadru kushtha like Kandu(itching),
Raga (redness), Pidika (papules/ elevation of skin), Mandala (rings).
Patients of age group between 18 to 60 years of age are included.
Patients of both sexes.
Patients willing to participate in study and those who give written consent. |
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age.
Patients with other Skin Disorders like Eczema, Psoriasis.
Pregnant women and lactating women.
Virechan anarha rugna/ Patients not eligible for Virechan karma.
Patients suffering from any chronic major illness.
Patients suffering from auto-immune disorders like SLE. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Better symptomatic releif in Mandala, Kandu, raga, pidaka using Trivrittadi kashaya
|
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief in kandu, mandala, raga, pidaka |
15 Days |
|
|
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)
|
30/11/2023 |
| 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="0"
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 kushtha is a type of Kushtha that comes under Mahakushtha by acharya Sushruta and under Kshudrakushtha by Acharya Charak . And also according to Charak it is 4th skin layer’s disease. Dadru can be correlated with Ringworm or Tinea corporis. And the incidance rate of Dadru is 20- 25% in India as per WHO and is seen among the people of every age group. Tinea is a superficial fungal infections mostly caused by three species of fungi. Hence there is a need of research for treatment of Dadru kushtha by Panchakarma Treattment. In kushtha chikitsa adhyay of Charak samhita and in Bhaishajya ratnavali a reference of virechan karma is observed i.e. by Trivritta, danti and triphala. So there is a need to evaluate the efficacy of virechan karma by this yoga and that by conventional Trivrutta avaleha. In Virechan Treatment we are going to give Ghritapan by Tiktak Ghrita until we get Samyak snigdha Lakshanas discussed in Snehadhyaya . After Snehapana there is rest period for 2 days in which there will be Sarwanga Snehana Swedana with Til tail. And on the third tday Virechan kalpa is administered by Oral route to the patient and Virechan karma lakshanas will be observed. After Virechan karma there will be follow up on 7th and 14th day. On follow up day there will assessment of Lakshanas of Dadru kushtha i.e. Upashay or Anupashaya. |