| CTRI Number |
CTRI/2023/07/055044 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of Aragvadha Patra Lepa and Aragvadha Kashaya in Eczema |
|
Scientific Title of Study
|
Analytical and clinical Study of aragvadha patra lepa with aragvadha Kashaya in vicharchika |
| 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 Suresh Chaubey |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University,Haridwar |
| Address |
P.G Department Dravyaguna
Rishikul Campus Haridwar Uttarakhand Ayurved University
Haridwar,Uttarakhand 249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9452811909 |
| Fax |
|
| Email |
sureshdr235@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Suresh Chaubey |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University Haridwar |
| Address |
P.G. Department of Dravyaguna,
Rishikul Campus, Haridwar Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9452811909 |
| Fax |
|
| Email |
sureshdr235@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Bisht |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University Haridwar |
| Address |
P.G Department of Dravyaguna Rishikul Campus, Haridwar Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8126215792 |
| Fax |
|
| Email |
manishabisht57@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No-1,Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University,Railway Road Harrawala Dehradun |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Manisha Bisht |
Rishikul Campus Haridwar |
OPD NO-1 & IPD of Kayachikitsa Department Rishikul Campus Haridwar Uttrakhand Ayurved University Haridwar Uttrakhand
249401 India
Hardwar
UTTARANCHAL |
8126215792
manishabisht57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttrakhand Ayurved University ,Rishikul Campus Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragvadha Kashaya, Reference: Ch.Su.25/40, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Ch.Chi. 7/96, Procedure details: In this procedure, the paste is applied externally on the affected part of the body.)
(1) Medicine Name: Aragvadha patra lepa, Reference: Ch.chi. 7/96, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 12(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 20 to 60 years.
2. Classical symptoms of Vicharchika like -
3. Kandu (itching), Pidika (eruption), Vaivarnyata (discoloration), Daha (burning sensation),Rukshata( dryness) Vedana( pain).
4. Patient willing to participate in above mentioned trial with informed consent. |
|
| ExclusionCriteria |
| Details |
1. Age group less than 20 year and more than 60 year.
2. Pregnant and lactating women.
3. Patient with other cutaneous symptoms of psoriasis, leprosy, local burn etc.
4. Any other secondary skin diseases.
5. Uncontrolled diabetic patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
1. Kandu (itching)
2. Daha (burning sensation )
3. Vedana (Pain)
4. Vaivarnyata (Discoloration)
5. Pidika (Eruption)
6. Rukshata (Dryness) |
0,10,20,30,45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onjective parameters
1. No. of lesion
2. Area occupied by the lesion |
0,10,20,30,45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
19/07/2023 |
| 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="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
|
This study is an open label randomized clinical trial to see the clinical effect of Aragvadha patra lepa with Aragvadh Kashaya in Vicharchika. In this trial, patients with classical symptoms of vicharhika will be selected from OPD and IPD of Kayachikitsa department of Rishikul campus Uttarakhand Ayurved University Haridwar. In this study, 30 patients will be selected and will be given Aragvadha Kashaya orally and Aragvadha patra lepa for external application for 30 days. Assessment will be done on the basis of various parameters as before and after the treatment is done. |