| CTRI Number |
CTRI/2024/10/075781 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study Of Sheetpitta Prabhanjan Ras(Herbal drug) With Navkarshik Guggul(Herbal Tablet)In Management Of itching with redness. |
|
Scientific Title of Study
|
Randomised Control Study of sheetpitta Prabhanjan Ras with Navkarshik Guggul in management of Sheetpitta |
| 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 Snehal Sanjay Dhawale |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Tilak ayurved mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,
Department of Kayachikitsa 1st floor, 583/2 Rasta peth Pune
411011
Pune
MAHARASHTRA
411011
India |
| Phone |
8378049898 |
| Fax |
|
| Email |
snehalsdhawale1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadanand V Deshpande |
| Designation |
HOD Department of Kayachikitsa |
| Affiliation |
Tilak ayurved mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,
Department of Kayachikitsa 1st floor, 583/2 Rasta peth Pune
411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Sanjay Dhawale |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Tilak ayurved mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,
Department of Kayachikitsa 1st floor, 583/2 Rasta peth Pune
411011
Pune
MAHARASHTRA
411011
India |
| Phone |
8378049898 |
| Fax |
|
| Email |
snehalsdhawale1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Aayurvedic Hospital,580/2 Rasta peth pune,411011,Maharashtra,India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,
Department of Kayachikitsa 1st floor, 583/2 Rasta peth Pune
411011 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrSnehal Dhawale |
Seth Tarachand Ramnath Aayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya 1st floor kayachikitsa department rasta peth 583/2 pune Pune MAHARASHTRA
Pune
MAHARASHTRA |
8378049898
snehalsdhawale1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,TAMV Pune |
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: SITAPITTAM, (2) ICD-10 Condition:L502||Urticaria due to cold and heat. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shitpitta Prabhanjan Ras, Reference: Rasyogsagar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navkarshik Guggul, Reference: Bhavprakash madhyam khand, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of religion.
Participants with classical symptoms of sheetpitta like kandu,tod,varatidanshtra sansthan shoth, vidah.
Both fresh and on treatment cases of sheetpitta. |
|
| ExclusionCriteria |
| Details |
Participants suffering from systemic disorders like uncontrolled DM,HIV.
Participants having patches due to burning and chemical explosion.
Pregnancy and lactating mother. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Deecrease in the symptoms of sheetpitta like itching,burnings and pricking sensation |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in the symptoms of itching, burning & pricking sensation & swelling |
28 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/11/2024 |
| 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
|
The Study will be Intervened by the Treatment of Sheetpitta Prabhanjan Ras and Navkarshik Guggul to Group A and Group B respectively.The efficacy of therapy will be assessed on the basis of subjective criteria for ststastical analysis.Scoring will be designed according to the severity of symptoms .The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment,after treatment and after follow up.The effect of treatment result will be assessed in regards to clinical signs and symptoms will be assessed by adopting the suitable scoring method. |