| CTRI Number |
CTRI/2024/12/077525 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Nimbapatra yoga in the acute urticaria. |
|
Scientific Title of Study
|
Clinical study to evaluate the role of Nimbapatra yoga in the management of sheetpitta with special refererence to acute urticaria. |
| 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 Aniket Joshi |
| Designation |
Asso.Professor |
| Affiliation |
Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Islampur,Tal -Walwa,Dist -Sangli |
| Address |
opd no.1 Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Post Graduate and Institute and Research Centre,Islampur,Tal -Walwa,Dist -Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890890889 |
| Fax |
|
| Email |
vdaniket@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aniket Joshi |
| Designation |
Asso.Professor |
| Affiliation |
Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Islampur,Tal -Walwa,Dist -Sangli |
| Address |
opd no.1 Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Post Graduate and Institute and Research Centre,Islampur,Tal -Walwa,Dist -Sangli
MAHARASHTRA
415409
India |
| Phone |
9890890889 |
| Fax |
|
| Email |
vdaniket@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniket Joshi |
| Designation |
Asso.Professor |
| Affiliation |
Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Islampur,Tal -Walwa,Dist -Sangli |
| Address |
opd no.1 Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Post Graduate and Institute and Research Centre,Islampur,Tal -Walwa,Dist -Sangli
MAHARASHTRA
415409
India |
| Phone |
9890890889 |
| Fax |
|
| Email |
vdaniket@gmail.com |
|
|
Source of Monetary or Material Support
|
| opd no:1 Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Post Graduate and Institute and Research Centre,Islampur,Tal -Walwa,Dist -Sangli 415409 |
|
|
Primary Sponsor
|
| Name |
Snehal Bhalchandra Vibhute |
| Address |
opd no.1 Loknete Rajarambapu Patil Ayurveda Medical College and Hospital,Post Graduate and Institute and Research Centre,Islampur,Tal -Walwa,Dist -Sangli 415409 |
| Type of Sponsor |
Private medical college |
|
|
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 Snehal Bhalchandra Vibhute |
Loknete Rajarambapu Patil Ayurved Medical Hospital, Islampur |
opd no:1,Kaychikitsa opd Islampur,Tal -Walwa,Dist -Sangli 415409.
Sangli
MAHARASHTRA |
9552326800
snehvibhute@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurveda Mahavidyalaya ,Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbapatra Yoga, Reference: Yog Ratnakar part 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -goghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The patient will be selected irrespective of gender, religion, occupation, marital status.
Patients with classical symptoms of Sheetpitta viz mandalotpatti, utsedha, toda, daha, kandu will be included in our study.
Patients with Acute Urticaria (It lasts for less than six weeks).
Patients between 20 to 40 years age. |
|
| ExclusionCriteria |
| Details |
Drug induced Urticaria.
Patients having history of any chronic diseases.e.g. Heart diseases, Paralysis, Diabetes Mellitus, Hypertension, Chronic Kidney Disease, HIV.
Patients having the symptom of
Jwara,chardi are excluded.
Hypersensitivity reactions to any drug.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinical study of Nimbapatra yoga in Sheetpitta with special reference to acute urticaria . |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study physiochemical & phytochemical properties of Nimba & Amlaki dravya.
To study Nimba & Amlaki dravya from various samhitas & nighantus in detail.
To study Sheetpitta from ayurvedic literature.
To study urticaria in detail. |
18 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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
|
Regardless of wide reasearch,detail understanding and treatment modalities it’s still remains to be cause of concern due to it’s requrrent nature,in this study of randomised clinical study to evaluate the role of Nimbapatra Yoga in the management of Sheetpitta with special reference to acute urticaria,60 pateints will be taken ,all 60 pateints will be given Nimbapatra Yoga orally and further research will be concluded. |