| CTRI Number |
CTRI/2022/06/043083 [Registered on: 08/06/2022] Trial Registered Prospectively |
| Last Modified On: |
07/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare efficacy of AGNIMANTH MOOL CHOORNA AND HARIDRAKHANDA CHOORNA in management of SHEETPITTA.(URTICARIA) |
|
Scientific Title of Study
|
’A RANDOMISED CONTROLLED CLINICAL STUDY OF AGNIMANTH MOOL CHOORNA AND HARIDRAKHANDA CHOORNA IN THE MANAGEMENT OF SHEETPITTA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR YOGENDRA YASHWANT MORE |
| Designation |
PG Student BAMS MD |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
|
| Fax |
|
| Email |
dryogendramore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Khobragde |
| Designation |
Asso Professor & Guide (Kaychikitsa Department) |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
|
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YOGENDRA YASHWANT MORE |
| Designation |
PG Student BAMS MD |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
|
| Fax |
|
| Email |
dryogendramore@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College Of Ayurved And Research Centre Akurdi PUNE Nigdi Pradhikaran Sector 25 |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi Pune |
| Address |
Nigdi Pradhikaran sec.no 25 Akurdi Pune |
| 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 YOGENDRA MORE |
Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi |
OPD NO 117 BHEL CHOWK NIGDI PUNE 44 Pune MAHARASHTRA
Pune
MAHARASHTRA |
8830579647
dryogendramore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEA College of Ayurveda and Research Center Akurdi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnimanthmool choorna |
Agnimanthmool choorna Is Prepared As Per Ayurved Text.Dose-3 gms,Frequency-twice a day,Duration-1 month,Route- oral |
| Comparator Agent |
Haridrakhanda Choorna |
Haridrakhanda Choorna Is Prepared As Per Ayurved Text.Dose-1 gm,Frequency-twice a day,Duration-1 month,Route- oral. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between ages 20-60 yrs irrespective of gender,religion & occupation.
Patients having Granthokt lakshanas of sheetpitta |
|
| ExclusionCriteria |
| Details |
Patients having any associated major illness like 1) Renal failure. 2) Diabetes mellitus. 3) Systemic Lupus Erythematous. 4) Rheumatic disorders. 5) Any type of malignant diseases e.g. Leukaemia metastatic cancer etc.
Patient taking treatment from any other pathy for the same problem.
Hypersensitivity reactions to any drug.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of AGNIMANTH MOOL CHOORNA AND HARIDRAKHANDA CHOORNA in the management of Sheetpitta(Urticaria). |
30 Days on follow up on 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study The Side Effects of Drug If Any. |
30 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 3 |
|
Date of First Enrollment (India)
|
10/06/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized clinical study parallel group comparing efficacy of Agnimanth mool choorna 3 gms twice a day and Haridrakhanda Choorna 1 gm twice a day for 1 month in 60 patients with Shitpitta(urticaria).. |