| CTRI Number |
CTRI/2024/05/067531 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Trial to Study The Effect of Haritaki and Nimba Choorn in Dadru Roga |
|
Scientific Title of Study
|
A pharmaco-therapeutic action of Haritaki (Terminalia chebula) and Nimba
(Azadirachta indica) in Dadru roga. |
| 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 Dinesh Chandra Joshi |
| Designation |
M.D Scholar |
| Affiliation |
Goverment Ayurvedic College and Hospital Patna Bihar |
| Address |
Department of Dravyaguna Government Ayurvedic College and Hospital Patna Bihar
800003
India
Patna
BIHAR
800003
India |
| Phone |
8958104831 |
| Fax |
|
| Email |
dineshj073@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sampurna Nand Tiwari |
| Designation |
Professor |
| Affiliation |
Goverment Ayurvedic College and Hospital Patna Bihar |
| Address |
Department of Dravyaguna Government Ayurvedic College and Hospital Patna
800003
India
Saran
BIHAR
800003
India |
| Phone |
7903144598 |
| Fax |
|
| Email |
dtiwariayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sampurna Nand Tiwari |
| Designation |
Professor |
| Affiliation |
Goverment Ayurvedic College and Hospital Patna |
| Address |
Department of Dravyaguna Government Ayurvedic College and Hospital Patna
BIHAR
800003
India
Saran
BIHAR
800003
India |
| Phone |
7903144598 |
| Fax |
|
| Email |
dtiwariayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deparment of Dravyaguna,OPD Room No-10 Government Ayurvedic College and Hospital Kadamkuan,near budhmurti,800003,India |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar |
| Address |
Department of Dravyaguna Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar 800003 |
| 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 Dinesh chandra Joshi |
Government Ayurvedic College and Hospital Patna Bihar |
Department of Dravyaguna OPD Room no-10
Patna
BIHAR |
8958104831
-
dineshj073@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki churn, Reference: Vangasen samhita,Ajirna adhikar 38/15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Neem churn, Reference: Vangasen Samhita,Ajirna adhikar 38/15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing for trial and give written informed consent.
2.Patient having classical feature of Dadru Kustha will be included.
3.The age group of patients will be between 20-60 yrs. |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from diseases like AIDS, Cancer, TB, Cardiac problems etc.
2.Patient suffering from systemic disorder like Diabetes, Renal stricture, hepatic
disorder is excluded.
3.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of Dadru (Tinea corporis) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the Effectiveness of Haritaki churn in Kandu, Raaga, Mandala
2.To assess the Effectiveness of Nimba churn in Kandu,Raaga,Mandala
3.To compare the Effectiveness of Haritaki churn & Nimba churn in Kandu, Raaga & Mandala |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/05/2024 |
| Date of Study Completion (India) |
28/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Dadru is a skin disorder. The skin is the outer covering and the largest organ of the human body. It is Raktapradoshaja vyadhi having kapha, pitta dominance. As per this definition the reddish colour pidika (boil) in the form of mandala with elevated borders with itching is known as Dadru and it is due to involvement of Kapha & pitta dosha. The drug used in this trial is Haritaki choorn and Nimba choorn mention in Ayurveda text with the hope that they will prove more efficacious, less toxic and easy to use. This drug is easily available, chief and effective in Dadru. Duration of treatment is 60 days. Patient will be taken from OPD and IPD of Government Ayurvedic College and Hospital, Patna. The duration of trial is 30 days. |