| CTRI Number |
CTRI/2025/08/092234 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the krishnajirak fant as gandush upkram in mukhapak |
|
Scientific Title of Study
|
Randomized Control Clinical Trial To Study The Efficacy of Krishnajirak Fant As Gandush Upkrama with Special Reference to mukhpaka |
| 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 Bhushan Dhonde |
| Designation |
Md Scoler |
| Affiliation |
LRP Medical College Peth Islampur |
| Address |
Room No 5 Devision Swasthvritta LRP Medical College Peth Islampur Rd Uran Islampur Maharashtra 415409
Room no 5 department of swasthvritta LRP Medical College Peth Islampur Rd Uran Islampur Maharashtra 415409 dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9130639222 |
| Fax |
0 |
| Email |
bhushandhonde3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Nakil |
| Designation |
Pg Guide Hod Of Swasthvritta Department |
| Affiliation |
LRP Medical College Peth Islampur |
| Address |
Department of swasthvritta Medical College Peth Islampur Rd Uran Islampur Maharashtra 415409 Dist Sangli
department of swasthvritta College Peth Islampur Rd Uran Islampur Maharashtra 415409 dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
0 |
| Email |
rahulnakil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Nakil |
| Designation |
Pg Guide Hod Of Swasthvritta Department |
| Affiliation |
LRP Medical College Peth Islampur |
| Address |
Department of swasthvritta Medical College Peth Islampur Rd Uran Islampur Maharashtra 415409 Dist Sangli
Department Of Swasthvritta Medical College Peth Islampur Rd Uran Islampur Maharashtra 415409 Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
0 |
| Email |
rahulnakil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College Hospital Post Gradute Institute ResearchCenter Islampur 415409 Dist Sangli |
|
|
Primary Sponsor
|
| Name |
LOKNETE RAJARAMBAPU PATIL AYURVEDIC MEDICAL COLLEGE HOSPITAL POST GRADUATE CENTRE |
| Address |
Loknete Rajarambapu Patil Ayurvedic Medical College Peth Islampur Road Uran Islampur Maharashtra 415409 Dist Sangli |
| 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 Bhushan Dhonde |
LRP Ayurvedic College Islampur |
Room no 5 Swasthavritta Department Loknete Rajarambapu Patil Ayurvedic MedicalCollege Hospital Post Gradute Institute & Research Center,Islampur 415409 Dist.Sangli Loknete Rajarambapu Patil AyurvedicMedical College Hospital,Post Gradute Institute & Research Center Islampur 415409 Dist.SangliSangliMAHARASHTRA415409India
Sangli
MAHARASHTRA |
09130639222
bhushandhonde3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete RajarambapuPatil Ayurvedic MedicalCollege Hospital PostGradute Institute and Research CenterIslampur 415409 Dist |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L898||Pressure ulcer of other site. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Krishnajirak phanta, Reference: (Cha 56/26)12, Route: Oral, Dosage Form: Phanta, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu churna , Reference: अ हृ.सु. २२/१२००/)7, Route: Oral, Dosage Form: Phanta, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Age-Patient between the groups of 18 to 50yr
2)Patient of both gender will be included in the study.
3) Subjective parameter for inclusion.
|
|
| ExclusionCriteria |
| Details |
1) Unconscious, poisoned, weak person patient suffering from bleeding disorder.
2) Patient having chronic or carcinogenic ulcer in oral cavity.
3)Mukhapak due to any other disorder e.g-Syphilis, AIDS, Dengue hemorrhage fever etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To compare the efficacy of
Krushnajirkadi fant in the management of Mukhpak.
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce sings and symptoms of mukhapak |
12th day |
|
|
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)
|
14/08/2025 |
| 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="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
|
Primary objective 1]Study on efficacy of krishnajirak churna as an upkrama in mukhpaka Secondary objective 2] To study importance of gandush described in Ayurveda sanhita to assess effect of krushnajirkadi churna in mukhapak
Participants - 60 adults diagnosed with Mukhpaka meeting inclusion and exclusion criteria from OPD and IPD of department of swasthvritta of Loknete Rajarambapu Patil Ayurvedic Medical College Hospital Post Graduate Institute & Research Center
Treatment Duration - 7 days
Follow up : 0th day, 2th day, 4th 7th day.
Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the Primary and Secondary outcomes.
Ethical Consideration - The study will be conducted in accordance with ethical guidelines and with Informed consent from participants. |