| CTRI Number |
CTRI/2024/11/077186 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the clinical Effect of Haridradi kashay ghana vati and Kaishor Guggul in Dadru (Tinea Corporis) in 62 patients. |
|
Scientific Title of Study
|
An open randomized comparative clinical study to evaluate the efficacy of Ghanvati of Haridradi kashay and Kaishore guggul in the management of Dadru. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Manoj Gidwani |
| Designation |
post graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of Kayachikitsa, 4th floor APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9545998881 |
| Fax |
|
| Email |
priyagidwani6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Paradkar |
| Designation |
Associate Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Kayachikitsa
APMs Ayurved Mahavidyalaya, Near Sion Station, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9987519315 |
| Fax |
|
| Email |
hemant.paradkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Paradkar |
| Designation |
Associate Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Kayachikitsa
APMs Ayurved Mahavidyalaya, Near Sion Station, Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9987519315 |
| Fax |
|
| Email |
hemant.paradkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvidya Prasarak Mandal Near Sion Railway Station Sion East Mumbai 400022. Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Priya Manoj Gidwani |
| Address |
APMs Ayurved Mahavidyalaya sion near sion railway station sion Mumbai 400022 |
| 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 |
| Priya Manoj Gidwani |
APMs Seth R V Ayurvedic Hospital |
Department of Kayachikitsa, room no 9, near Sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA |
9545998881
priyagidwani6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishore Guggulu, Reference: Sharangdhar Samhita Madhyam khanda 7/72-81, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradi Kashaya, Reference: Bharat bhaishajya ratnakar hakaradi kashaya prakarana 8418, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 80 years.
2) Sex: All Genders
3) Patient with classical signs and symptoms of Dadru like Kandu, Pidika, Raga and Daha.
4) Understanding and willing to sign the informed consent form.
5) Chronicity of disease should be less than 2 years.
6) Area of lesion up to 25cm sq. |
|
| ExclusionCriteria |
| Details |
1. Patients having skin lesions other than Dadrukushta (Tinea corporis) like Eczema, psoriasis,
urticaria etc.
2. Pregnancy and lactating mother.
3. Immuno-compromised patients like AIDS (HIV positive), HbSAg positive etc.
4. Chronicity of disease more than 2 years. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
size of lesion
number of lesion |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Kandu (Itching)
2) Raga (Erythema)
3) Pidka (papule)
4) Daha (burning) |
28 days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 4 |
|
Date of First Enrollment (India)
|
27/11/2024 |
| 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
|
According to Acharya Charak, out of six layers of Twacha, Dadru is the Vyadhi of Chaturtha Twacha. Ancient scholars of Ayurveda have mentioned many oral medications along with local formulation in the treatment of Dadru. As the local formulation has proven efficacy in skin disorders than oral formulations. To check the efficacy of oral administration of drugs in Dadru, the study has chosen. So I have decided to study the effect of Oral administration of Ghanvati of ’Haridradi Kashay’ and ‘Kaishore Guggul†in Dadru. In Ayurveda for the treatment of Dadru; there are various formulations which can be used internally as well as externally. It is necessary to study and evaluate the efficacy of these drugs scientifically. So I have decided to study the effect of Oral administration of Ghanvati of ’Haridradi Kashay’ and ‘Kaishore Guggul’ ’ in Dadru. |