| CTRI Number |
CTRI/2023/03/051024 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Arka Taila (oil) and Arka Malahar (ointment) on Vicharchika (skin disease) for external application
|
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARKA TAILA ALONG WITH ARKA MALAHAR AS TOPICAL APPLICATION IN THE MANAGEMENT OF VICHARCHIKA
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHAGAWAN GOPALGHARE |
| Designation |
PG SCHOLAR DEPARTMENT OF ROG NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
CCL Department of Rog Nidan Evum Vikriti Vigyan, Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
CCL Department of Rog Nidan Evum Vikriti Vigyan, Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7841979955 |
| Fax |
|
| Email |
drbhagawan.g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SACHIN GOPALDAS ROHANI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
CCL Department of Rog Nidan Evum Vikriti Vigyan, Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
CCL Department of Rog Nidan Evum Vikriti Vigyan, Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9730490300 |
| Fax |
|
| Email |
sachinrohani1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAGAWAN GOPALGHARE |
| Designation |
PG SCHOLAR DEPARTMENT OF ROG NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
CCL Department of Rog Nidan Evum Vikriti Vigyan, Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
CCL Department of Rog Nidan Evum Vikriti Vigyan, Dr DY Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7841979955 |
| Fax |
|
| Email |
drbhagawan.g@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
DR BHAGAWAN GOPALGHARE |
| Address |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 411018 |
| Type of Sponsor |
Other [Self] |
|
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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 Bhagawan Gopalghare |
Dr D Y Patil Ayurved Hospital And Research Centre Pimpri Pune |
OPD no 15 of Dr D Y Patil Ayurved Hospital And Research Centre Ground Floor Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
7841979955
drbhagawan.g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Arka Malahar, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arka Taila, Reference: Sharangdharsamhita 147, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients will be selected irrespective of sex and socio economic status
2 Patients between the age group of 18 to 70yrs will be included in the study
3 Patients with complaints of Kandu Pidika Raji Shyava Rukshata Utsedh itching pustules discolouration dryness swelling
|
|
| ExclusionCriteria |
| Details |
1 Patients on steroid ointments
2 Patients having other skin disease like leprosy lichen planus
3 Patient with symptoms like redness pustules vesicle
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the efficacy of ArkaMalahara in the management of Vicharchika
2 To evaluate the efficacy of ArkaTaila in the management of Vicharchika
3 To compare the efficacy of ArkaTaila and ArkaMalahara in the management of Vicharchika
|
Follow up will be on 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To Study The Adverse Effect Of Arka Malhar
2 To compare the efficacy of ArkaTaila and ArkaMalahara in the management of Vicharchika
|
Follow up will be on 15th days |
|
|
Target Sample Size
|
Total Sample Size="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is Randomized comparative clinical study to be held on two groups of each 30 patients of vicharchika.In group A we are using arka taila and In Group B We are using arka malahar for external application on affected part of skin Daily twice a day for 15 days and then follow up will be on 15th day .This research is planned with objective to find out the individual and Comparitive Clinical efficacy of Arka Taila and Arka Malahar |