| CTRI Number |
CTRI/2024/10/075775 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nimbatwaka Churna and Chakramarda Beej Churna in the management of Dadru kushtha (tinea corporis) |
|
Scientific Title of Study
|
Effect of Nimbatwaka Churna and Chakramarda Beej Churna in the management of Dadru Kushtha in adults with special refrence to Tinea Corporis: A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Amol Dnyaneshwar Dhanait |
| Designation |
Pg scholar |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikitsa department shri ayurved mahavidyalaya, pakwasa samanvaya rugnalaya hanuman nagar nagpur Maharashtra 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8975775738 |
| Fax |
|
| Email |
dhanaitamol@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Archana Dachewar |
| Designation |
Hod and professor |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikitsa department shri ayurved mahavidyalaya, pakwasa samanvaya rugnalaya hanuman nagar nagpur Maharashtra 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Archana Dachewar |
| Designation |
Hod and professor |
| Affiliation |
Shri ayurved mahavidyalaya nagpur |
| Address |
Kayachikitsa department shri ayurved mahavidyalaya, pakwasa samanvaya rugnalaya hanuman nagar nagpur Maharashtra 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822206312 |
| Fax |
|
| Email |
dr.dachewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikista department shri ayurved mahavidyalaya pakwasa samanvaya rugnalaya hanuman nagar nagpur Maharashtra India 440024 |
|
|
Primary Sponsor
|
| Name |
Vd Amol Dnyaneshwar Dhanait |
| Address |
Kayachikitsa department Shri Ayurved Mahavidyalaya hanuman nagar Nagpur 440024 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Vd Amol Dnyaneshwar Dhanait |
Shri Ayurved Mahavidyalaya nagpur |
Kayachikitsa department Shri Ayurved Mahavidyalaya Hanuman nagar Nagpur 440024
Nagpur
MAHARASHTRA |
8975775738
dhanaitamol@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Shri Ayurved Mahavidyalaya Nagpur |
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 | Drug | Classical | | (1) Medicine Name: Nimbatwaka Churna, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chakramarda Beej Churna, Reference: Dhanvantari Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having chronicity less than 2 yrs.
2. Patient with sign and symptoms like kandu, pidaka, vaivarnya, mandala.
3. Newely diagnosed cases of dadru. |
|
| ExclusionCriteria |
| Details |
1. Patient having systemic disease like T.B, Malignancy, Asthma,etc.
2. Dadru associated with other skin diseases like herpes, scabies, diabetic wounds, malignancy, eczema.
3. Patient on steroids treatment and any other drug who affecting the outcome of the study. 4.Pregnancy and lactating mothers.
5. Immuno-compromised patients like HIV, HBSAg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effectiveness of Nimbatwaka Churna And Chakramarda Beej Churna in reduction of mandalas( size of patches)in dadru kushtha(tinea carporis) |
Follow up on 0,15,30,45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Nimbatwaka churna & Chakramarda beej churna in the reduction of kandu(itching) in dadru kushtha (tinea carporis) |
Follow up on 0,15,30,45 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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
|
In the present study, total 72 participants will be taken for trial dividing them in equal groups. Group-A will receive the trial drug " Nimbatwaka churna" and Group-B will receive control drug "Chakramarda Beej Churna" twice a day for internally for 45 days.follow up will be taken every 15 days.result will be concluded based on assessment criteria. |