| CTRI Number |
CTRI/2025/07/090129 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [nil] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role Of Saptachhadadi Kashaya Gandusha And Pana In Mukhapaka |
|
Scientific Title of Study
|
A CLINICAL COMPARATIVE STUDY OF SAPTACHHADADI KASHAYA GANDUSHA AND SAPTACHHADADI KASHAYA PANA IN MUKHAPAKA |
| 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 Suresh Singh Lodhi |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of swasthvritta & yoga , O.P.D. No. 02,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9644136521 |
| Fax |
|
| Email |
hserus521@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamata P Tirankar |
| Designation |
Associate Professor Department Of Swasthvritta |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of swasthvritta & yoga , O.P.D. No. 02 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9644136521 |
| Fax |
|
| Email |
tirankarmamata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Singh Lodhi |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
Department of swasthvritta & yoga , O.P.D. No. 02 , Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9644136521 |
| Fax |
|
| Email |
hserus521@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal462044 |
|
|
Primary Sponsor
|
| Name |
Dr Suresh Singh Lodhi |
| Address |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal462044 |
| 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 Suresh Singh Lodhi |
Rani Dullaiya Smriti Ayurved PG College And Hospital Kalan Bhadbhada Road Bhopal 462044 |
OPD No 2 Department Of Swasthvritta Rani Dullaiya Smriti Ayurved PG College And Hospital Kalan Bhadbhada Road Bhopal 462044
Bhopal
MADHYA PRADESH |
9644136521
hserus521@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K123||Oral mucositis (ulcerative), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Saptachhadadi kashaya gandush |
Saptachhadadi kashaya gandush ( oral route )in mukhapaka for 7 days od morning time |
| Comparator Agent |
Saptachhadadi kashaya paan |
Saptachhadadi kashaya paan ( oral route ) in mukhapaka for 7 days od morning time |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Lakshanas of Mukhapaka will be selected.
Patients of age above 20- 50 year will be selected.
Patients of any genders will be included irrespective of their religion & caste.
4. Patients fit for Gandusha Dharan and Kashaya Pana will be selected. |
|
| ExclusionCriteria |
| Details |
Patients of below 20 and above 50 years of age will be excluded.
Patients suffering from any systemic disorders will be excluded.
Patients suffering from CA of oral cavity, Toothache will be excluded.
Patients unfit for Gandusha Dharana and Kashaya Pana will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient will get relief from muhpaka through ayuvedic drugs |
07 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| study the effect of saptachhadadi kashaya gandush and in paan form |
7 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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 is a double group , open label comparative To study the effect of Saptachhadadi kashaya Gandusha Dharana and Saptachhadadi kashaya Pana in treating the Mukhapaka.along with comaprison between two forms. Along with objectives to To collect litarature review from various samhitas and To preparation of drug & standardization of prepared drug . |