| CTRI Number |
CTRI/2023/07/054869 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Raktamokshan with Jalauka and Vidangadi Lepa and Vidangadi Lepa] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Jalauka-Avcharan and Vidangadi Lepa in the management of Dadru (Dermatophytosis). |
|
Scientific Title of Study
|
A Comparative Clinical Study of Jalauka-Avcharan & Vidangadi Lepa in the Management of Dadru (Dermatophytosis) |
| 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 Neha Bisht |
| Designation |
MD Scholar |
| Affiliation |
Government PG Ayurveda College and Hospital Varanasi |
| Address |
OPD no 11
Department of Panchakarma
Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8273321161 |
| Fax |
|
| Email |
nee8273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Mishra |
| Designation |
Lecturer |
| Affiliation |
Government PG Ayurveda College and Hospital Varanasi |
| Address |
OPD no 11
Department of Panchakarma
Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9415896482 |
| Fax |
|
| Email |
manish.arnav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Bisht |
| Designation |
MD Scholar |
| Affiliation |
Government PG Ayurveda College and Hospital Varanasi |
| Address |
OPD no 11
Department of Panchakarma
Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8273321161 |
| Fax |
|
| Email |
nee8273@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda College and Hospital Varanasi 221002 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and Hospital Varanasi Uttar Pradesh India |
| Address |
Government PG Ayurveda College and Hospital Varanasi Uttar Pradesh India |
| 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 Neha Bisht |
Government PG Ayurveda College and Hospital Varanasi 221002 UP |
Department of Panchakarma
Government PG Ayurveda College and Hospital Varanasi 221002 UP
Varanasi
UTTAR PRADESH |
8273321161
nee8273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government Ayurveda College and Hospital, Varanasi, UP, Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Susruta samhita sutrasthana 13, Procedure details: Leech will be applied in the affected area after cleaning the area.)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: chakradutta 50/19, Procedure details: The contents mentioned in the vidangadi lepa is mixed with Dhanyamla and applied in the affected part.)
(1) Medicine Name: Vidangadi Lepa, Reference: Chakradutta chikitsa 50/19, Route: Topical, Dosage Form: Lepa Churna, Dose: 170(g), Frequency: bd, Duration: 17 Days | | 3 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠand Lepa | (Procedure Reference: Susruta samhita Sutrasthana 13, Procedure details: leeches will be applied in the affected part after cleaning the area.
vidangadi lepa will be applied after the leech therapy)
(1) Medicine Name: Vidangadi Lepa, Reference: Chakradutta Chikitsa 50/19, Route: Topical, Dosage Form: Lepa Churna, Dose: 170(g), Frequency: bd, Duration: 17 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients are selected irrespective of sex
occupation caste etc
2 Patients between age group 16 to 70 years are
included in the study
3 Patients with classical sign and symptoms of
Dadru will be taken
4 Patients having Hb value within normal range
more than 10 mg per dl
|
|
| ExclusionCriteria |
| Details |
1 Patient of age group less than 16 and and more
than 70 years
2 Patient who lies in the criteria of Raktamokshan
Ayogya
3 Patients having Hb below 10mg per dl
4 Immuno-compromised patient Uncontrolled Diabetes
Skin Cancer etc
5 Any haemorrhagic disorder or hereditary
conditions Thallesemia Sickle cell anemia etc
6 Pregnant and Lactating mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in redness & Itching |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in lesion size |
17 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
1. Comprehensive Review of Jalauka-Avcharan and Vidangadi Lepa in the management of Dadru (Dermatophytosis)
2. Management of Dadru Kustha through Ayurveda- A Case Study |
|
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 Interventional Open and Randomized group trial study, named- A COMPARATIVE CLINICAL STUDY OF JALAUKA-AVCHARAN AND VIDANGADI LEPA IN THE MANAGEMENT OF DADRU (DERMATOPHYTOSIS). A total number of 60 patients suffering from dadru will be randomly selected from OPD and IPD of Government PG Ayurveda College and Hospital, Varanasi and will be divided into three groups, each group having 20 patients. Group A- 20 patients will be treated with RAKTAMOKSHAN with the help of Jalauka of duration 17 days in three sittings. Group B- 20 patients will be treated with Vidangadi Lepa of duration 17 days. Group c- 20 patients will be given combined treatment of raktamokshan by jalauka along with Vidangadi Lepa of duration 17 days. Follow up- After completion of treatment course of 17 days, there will be three follow ups at the interval of seven days. First Follow up- At 7th day Second Follow up- At 14th day Third Follow up- At 21st day
|