| CTRI Number |
CTRI/2021/01/030549 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative effectof Bhallataka Vishadi Agada Lepa and Arka Taila Lepa on Eczema |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFICACY OF BHALLATAKA VISHADI AGADA LEPA AND ARKA TAILA LEPA IN THE MANAGEMENT OF VICHARCHIKA W.S.R. ECZEMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR L K PATTAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SVM AYURVEDIC MEDICAL COLLEGE |
| Address |
S.V.M.AYURVEDIC MEDICAL COLLEGE ILKAL
DEPT OF AGADA TANTRA
S.V.M.AYURVEDIC MEDICAL COLLEGE
MAHANT GANGOTRI
ILKAL
Bagalkot
KARNATAKA
587125
India |
| Phone |
9740790121 |
| Fax |
|
| Email |
lkpattar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR L K PATTAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SVM AYURVEDIC MEDICAL COLLEGE |
| Address |
S.V.M.AYURVEDIC MEDICAL COLLEGE ILKAL
DEPT OF AGADA TANTRA
S.V.M.AYURVEDIC MEDICAL COLLEGE
MAHANT GANGOTRI
ILKAL
Bagalkot
KARNATAKA
587125
India |
| Phone |
9740790121 |
| Fax |
|
| Email |
lkpattar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M R PANDYA |
| Designation |
PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA
LIMDA , GUJARAT
PARUL UNIVERSITY GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9998950228 |
| Fax |
|
| Email |
madhusudan.pandya@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| SVM AYURVEDIC MEDICAL COLLEGE & R P KARADI AURVEDIC HOSPITAL ILKAL |
|
|
Primary Sponsor
|
| Name |
DR L K PATTAR |
| Address |
SVM AYURVEDIC MEDICAL COLLEGE ILKAL |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR L K PATTAR |
PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY |
P.O.LIMDA, TQ.WAGHODIA
PIN:391760
Vadodara
GUJARAT |
9740790121
lkpattar@gmail.com |
| DR L K PATTAR |
SVM AYURVEDIC MEDICAL COLLEGE& R P KARADI AYURVEDIC HOSPITAL |
DEPT. OF AGADA TANTRA
MAHANT GANGOTRI CAMPUS, ILKAL 587125
Bagalkot
KARNATAKA |
9740790121
lkpattar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY, VADODARA, GUJARAT |
Approved |
| SVM AYURVEDIC MEDICAL COLLEGE ILKAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICHARCHIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EFFICACY OF ARKA TAILA LEPA IN VICHARCHIKA |
Group B 60 patients will be applied Arka Taila lepa daily for 45 days |
| Intervention |
EFFICACY OF BHALLATAKA AGADA LEPA IN VICHARCHIKA |
In Group A 60 patients will be applied Bhallataka Vishadi Agada lepa daily for 45 days |
| Comparator Agent |
EFFICACY OF BHALLATAKA VISHADI AGADA LEPA AND ARKA TAILA LEPA IN VICHARCHIKA |
A comparison will be done with Group A and Group B having 60 patients in each group will be applied Bhallataka Vishadi agada lepa and Arka Taila lepa respectively daily for 45 days.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as Vicharchika on the basis of Lakshanas like Kandu, Pidaka, Shyavavarna, with or without srava and Rukshata.
Patients who are willing to participate for the study
|
|
| ExclusionCriteria |
| Details |
Patients on steroid therapy.
Lesions with secondary infections.
Patients who are unfit for Lepana Karma.
Patients suffering from systemic disorders which interferes with the course of treatment.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
bhallataka vishadi lepa contains
the properties of laghu, rookshaguna, ushnaveerya, tridoshahara, kushtaghna and
krimighna which acts on Vicharchika |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Arka is Katu, Tikta Rasa, Laghu, Sara and Snigdha Guna, Ushna Virya,
Katu Vipaka.
So it balances the kapha and vata dosha on the level of skin
It is beneficial in the treatment of vicharchika |
45 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2021 |
| Date of Study Completion (India) |
15/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction Acharya Vagbhata in his Uttarasthana explained about utility of Visha and Prativisha prayogas in context of Vishopayogi Adhyaya and also mentioned about treatment modalities where rest all treatment modalities are failed to cure the disease . Method of collection of data a. Sample size: 120 Subjects will be selected for the clinical study b. Study design: A randomized comparative clinical study. c. Selection criteria: The cases are selected as per signs and symptoms mentioned in classics. The selected Subjects will be thoroughly examined on the basis of subjective and objective parameters. The subjective parameters & objective parameters will be analysed before and after treatment & The subjects will be selected from OPD & IPD of R P Karadi Ayurvedic hospital Ilkal. The improvement will be documented systematically and assessed through statistical method. Diagnostic criteria: Vicharchika laxana’s will be recorded with the interval of 15 days for 45 days. Assessment Criteria: 1. Kandu (itching) 2. Pidika (eruption) 3. Vaivarnya (depigmentation) 4. Srava (discharge) 5. Daha (burning sensation) 6. Shotha (oedema) 7. Vedana (pain) 8. Rukshata (dryness/roughness) Inclusion criteria · Subjects of either sex with the age group between 18 - 60 years, irrespective of occupation and economic status Subjects diagnosed as Vicharchika on the basis of Lakshanas like Kandu, Pidaka, Shyavavarna, with or without srava and Rukshata.
Exclusion Criteria Subjects on steroid therapy. Lesions with secondary infections. Subjects who are unfit for Lepana Karma. Subjects suffering from systemic disorders which interferes with the course of treatment. Subjects are randomly divided into two groups · Group-A: 60 Subjects will be applied Bhallataka Vishadi agada lepa twice daily for 45 days. · Group-B: 60 Subjects will be applied Arka Taila lepa twice daily for 45 days. |