| CTRI Number |
CTRI/2025/04/085758 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of Panchnnimbadi Churna and an etiopathological study on urticaria (sheetpitta) |
|
Scientific Title of Study
|
An Etiopathological Study of Urticaria (Sheetpitta) and Therapeutic trial of Panchnimbadi Churna |
| 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 Sunil kumar |
| Designation |
P.G Scholar |
| Affiliation |
Government ayurvedic college and hospital, Patna |
| Address |
Department of Rog Nidan and vikriti vigyan, Government of Ayurvedic college and hospital, Land mark- Buddha murti, Kadamkuan , Patna-800003, Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
7677667238 |
| Fax |
|
| Email |
bamssunilkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarendra kumar singh |
| Designation |
Associate professor deparment of rog nidan evam vikriti vigyan |
| Affiliation |
Government of Ayurvedic college and hospital, Patna |
| Address |
Department of Rog Nidan and vikriti vigyan, Government of Ayurvedic college and hospital, Land mark- Buddha murti, Kadamkuan , Patna-800003, Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
9931230820 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarendra kumar singh |
| Designation |
Associate professor deparment of rog nidan evam vikriti vigyan |
| Affiliation |
Government of Ayurvedic college and hospital, Patna |
| Address |
Department of Rog Nidan and vikriti vigyan, Government of Ayurvedic college and hospital, Land mark- Buddha murti, Kadamkuan , Patna-800003, Patna, Bihar
Patna
BIHAR
800003
India |
| Phone |
9931230820 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government of Ayurvedic college and hospital, Land mark- Buddha murti, Kadamkuan , Patna-800003, Patna, Bihar |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Kumar |
| Address |
Department of Rog Nidan and vikriti vigyan, Government of Ayurvedic college and hospital, Land mark- Buddha murti, Kadamkuan , Patna-800003, Patna, Bihar |
| 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 |
| DR SUNIL KUMAR |
GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA |
GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA
Patna
BIHAR |
7677667238
bamssunilkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government ayurvedic college and hospital patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PANCHNIMBADI CHURN, Reference: BHAVAPRAKASH, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-The sign and symptoms of Urticaria (Sheetpitta) based on both ayurvedic as well as modern view. |
|
| ExclusionCriteria |
| Details |
-Patients below 12 years and above 60 years.
-Immunocompromised patients example HIV.
-Patients is unwillings.
-Patients with complicated associated symptoms example severly ill liver cirrhosis adenocarcinoma.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign and symptoms will be assessed before and after treatment. i.e- Kandu, Mandalakar, Utsedna, Toda, Daha, Sotha etc |
Total 30 Patients
Duration- 60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CBC & LFT test will be done in patients before & after treatment |
Total- 30 Patients
Duration- 60 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STYDY IS SINGLE ARM TRIAL TO KNOW THE EFFECTNESS OF PANCHNIMBADI CHURN IN URTICARIA (SHEETPITTA) THAT WILL BE CONDUCTED IN GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA , IN THE DEPARTMENT OF ROG NIDIAN EVAM VIKRITI VIGYAN IN THE GROUP 30 PATIENTS AFTER THE 15 DAYS INTERVENTIONS, FOLLOW UP IS DONE AT EVERY 15 DAYS FOR THE ENTIRE DURATION OF THE STUDY, i,e 60 DAYS. |