| CTRI Number |
CTRI/2024/08/073054 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs Nimba rasakriya And daruharidra rasakriya in patients having Stomatitis |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study To Evalute The Efficacy Of Nimba Rasakriya with Gairik And Madhu Pratisaran In Mukhapaka With Special Reference To Stomatitis |
| 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 Annasaheb Ravsaheb Patil |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Department of Shalakyatantra
3rd floor
Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur
Department of Shalakyatantra 3rd floor
Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9762847199 |
| Fax |
|
| Email |
annapatil25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Balasaheb Patil |
| Designation |
Reader |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Department Of Shalakyatantra
Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur
Department of Shalakyatantra
Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annasaheb Ravsaheb Patil |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Department of Shalakyatantra
3rd floor
Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur
Deapartment of Shalakyatantra
3rd floor
Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9762847199 |
| Fax |
|
| Email |
annapatil25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic medical College Kodoli Dist Kolhapur State Maharashtra Country India 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Annasaheb Ravsaheb Patil |
| Address |
Department of Shalakyatantra
Yashwant Ayurvedic medical College Kodoli kolhapur
State Maharashtra Country India 416114 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Annasaheb Ravsaheb Patil |
Yashwant Dharamartha Rugnalaya Kodoli. |
Department of shalakyatantra Yashwant Ayurvedic medical College PGT and RC Kodoli kolhapur 416114
Kolhapur
MAHARASHTRA |
9762847199
annapatil25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECYashwantAyurvedicMedical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimba Rasakriya, Reference: Ashtang Hrudya uttarstana, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -with Gairik & Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Daruharidra Rasakriya, Reference: Ashtang Hrudaya Uttarstana, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -with Gairik & Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having ulcers in oral cavity
Patients with classical signs and symptoms of mukhapak |
|
| ExclusionCriteria |
| Details |
Known case of tubercular ulcer/syphilis ulcer/diabetic ulcers
Known case of oral throat tongue malignancy
Known case of HTN/DM |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain and burning sensation |
baseline 2 weeks & 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Lalima(congestion), decrease in size of ulcer |
30 days |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2024 |
| 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 Yet Recruiting |
| 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 study is Randomised open controlled clinical study to evaluate the efficacy of Nimba rasakriya with gairik and madhu pratisaran in mukhapak with special reference to stomatitis. Study will be carried in OPD of Shalakya tantra department of yashwant ayurvedic medical College and hospital Kodoli.The observation would be drawn on the basis of symptoms after treatment given |