| CTRI Number |
CTRI/2020/03/024047 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Ringworm through Malabar nut leaves (Justicia adhatoda L.) |
|
Scientific Title of Study
|
Clinical assessment of Vasa (Justicia adhatoda L.) in Dadru kushtha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harsh Upadhyay |
| Designation |
BAMS |
| Affiliation |
Government Ayurved college Vadodara |
| Address |
Dravyaguna department,
Government Ayurved college,
Ayurved tran rasta, Panigate, Vadodara-390019
Vadodara
GUJARAT
390019
India |
| Phone |
9408957575 |
| Fax |
|
| Email |
harshupadhyay07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Jani |
| Designation |
Professor |
| Affiliation |
Government Ayurved college Vadodara |
| Address |
Upgraded Department of Dravyaguna
Government Ayurved college,
Ayurved tran rasta, Panigate, Vadodara-390019
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Jani |
| Designation |
Professor |
| Affiliation |
Government Ayurved college Vadodara |
| Address |
Upgraded Department of Dravyaguna
Government Ayurved college,
Ayurved tran rasta, Panigate, Vadodara-390019
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
|
Source of Monetary or Material Support
|
| the Principal, Government Ayurved college Vadodara |
|
|
Primary Sponsor
|
| Name |
Government Ayurved college Vadodara |
| Address |
Government Ayurved college
Ayurved tran rasta Panigate Vadodara 390019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Harsh Upadhyay |
Government Ayurved College Vadodara |
Dravyaguna department,
Government Ayurved College Vadodara
Ayurved tran rasta, Panigate Vadodara 390019
Vadodara
GUJARAT |
9408957575
harshupadhyay07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nimba leaves (Azadirachta indica A.juss.) |
Orally- 40 ml kashay/bd- as per API (10 gram yavkut churna of Nimba leaves (Azadirachta indica A.juss.) +160 ml water ,socked it for 6-8 hrs. Then reduce water by 40 ml and take it luke warm)
Externally- Sukshma churna of Nimba leaves (Azadirachta indica A.juss.) applied with water on affected part of skin twice a day.
|
| Intervention |
Vasa leaves (Justicia adhatoda L.) |
Orally- 40 ml kashay/bd- as per API (10 gram Yavkut churna of Vasa (Justicia adhatoda L.) +160 ml water ,socked it for 6-8 hrs. Then reduce water by 40 ml and take it luke warm)
Externally- Sukshma churna of Vasa (Justicia adhatoda L.) applied with water on affected part of skin twice a day.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Based on clear sign and symptoms of Dadru kushtha fulfilling the diagnosis |
|
| ExclusionCriteria |
| Details |
Patients having age less than 18 years and more than 50 years.
Uncontrolled clinical conditions like Uncontrolled HTN, cancer, HIV, HBsAg, CKD, Liver cirrhosis, Cardiac failure, Stroke etc.
History of Metabolic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in classical symptoms of Dadru Kushtha |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in haematological examinations like Hb,total count, differential count, ESR |
21 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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2020 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Manuscript entitled "An Open Labelled, Parallel Arm Interventional Clinical Assessment of Vasa (Justicia adhatoda L.) in Dadru Kushtha (Fungal Skin Infection)" was submitted with reference number ayu_173_21 in AYU (An International Quarterly Journal of Research in Ayurveda). |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a Randomized clinical trail to evaluate the effect of Vasa (Justicia adhatoda L.) leaves powder and Nimba (Azadirachta indica A.Juss.) leaves powder in the management of Dadru Kushtha. Total 58 patients were screened among them total 36 patients were enrolled in present study and 32 patients were completed total duration of treatment. 4 patients were dropped out due to irregularity in treatment. Selected patients was divided in 2 groups on the basis of computer generated randomization. In this study Vasa is as a trail drug and Nimba is as a standard drug Orally- 40 ml kashay/bd- as per API (10 gram Yavkut churna of drug +160 ml water ,socked it for 6-8 hrs. Then reduce water by 40 ml and take it luke warm in morning and evening empty stomach), Externally- Sukshma churna of patra applied with water on affected part of Skin twice a day for 21 days. Follow up was carried out for 14 days. Clinical data obtained was summarized at the end of the study. Conclusion was made after the statistical analysis of the data. No any Adverse Drug reaction observed during and after treatment. |