| CTRI Number |
CTRI/2025/07/091836 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| 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 CLINICAL STUDY TO TEST THE EFFECT OF AYURVEDIC TREATMENT IN PATIENTS WITH REPEATED MOUTH ULCERS AND MOUTH OPENING DIFFICULTY |
|
Scientific Title of Study
|
RANDOMIZED OPEN LABELED CONTROLLED CLINICAL STUDY OF EFFICACY OF HARIDRADI TAILA MALAHAR PRATISARAN IN VATAJA PITTAJA MUKHPAKA WITH SPECIAL REFERENCE TO ORAL SUBMUCOUS FIBROSIS |
| 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 Pratibha Kondibarao Waghmare |
| Designation |
Assistant Professor PhD Scholar |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Government Ayurved College and Hospital Vazirabad Nanded
Maharashtra
431602
India
Nanded
MAHARASHTRA
431602
India |
| Phone |
9503779408 |
| Fax |
|
| Email |
pratibhawaghmare94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisar Ali Khan |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Government Ayurved College and Hospital Vazirabad Nanded
Maharashtra
431602
India
Nanded
MAHARASHTRA
431602
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
dr.khan_na@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Kondibarao Waghmare |
| Designation |
Assistant Professor PhD Scholar |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Government Ayurved College and Hospital Vazirabad Nanded
Maharashtra
431602
India
Nanded
MAHARASHTRA
431602
India |
| Phone |
9503779408 |
| Fax |
|
| Email |
pratibhawaghmare94@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No 24 Department of Shalakyatantra Government Ayurved College and Hospital Vazirabad Nanded
431601
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Pratibha Kondibarao Waghmare |
| Address |
Shalakyatantra Department Government Ayurved College and Hospital Vazirabad Nanded
431601
Maharashtra
India |
| 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 Pratibha Waghmare |
Government Ayurved College and Hospital Vazirabad Nanded 431602 |
Shalakyatantra Department
OPD NO 24
Vazirabad
Nanded
Nanded
MAHARASHTRA |
9503779408
pratibhawaghmare94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurved College Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K121||Other forms of stomatitis. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 41 pratisAraNam | (Procedure Reference: 41 pratisAraNam, Procedure details: Haridradi Taila Malahar 3 gm will be taken with the tip of finger and slowly scrubbed over the affected area or a gentle massage over on tongue and buccal cavity twice a day for 30 days)
| | 2 | Comparator Arm | Procedure | - | 41 pratisAraNam | (Procedure Reference: 41 pratisAraNam, Procedure details: Daruharidra Rasakriya 3 gm will be taken with the tip of fingers and slowly scrubbed over the affected area or a gentle massage over on the tongue and buccal cavity twice a day for 30 days )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient Selected As Per Diagnostic Criteria Of Oral Submucous Fibrosis |
|
| ExclusionCriteria |
| Details |
Patients Age Below 18 Years And Above 60 Years Suffering From Severe Trismus Interincisal distance of less than 0.5cm
Other Inflammatory Conditions of Oral Cavity Such as Candidiasis Herpes stomatitis Oral lichen planus Diphtheria
Congenital Maxillofacial deformities
Suspected or Diagnosed malignancy
Temporomandibular joint disorders
Other systemic disease which may cause oral lesion such as TB
Uncontrolled diabetes mellitus
Severe anemia less than 7 gm per dl
Patient suffering from Erythroplakia
Patients on immunosuppressant therapy
Acute infections or febrile illness
Patients not willing to give up habits of chewing gutka tobacco and betel nut |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in mouth opening |
Before Treatment 0 day
After Treatment 31 st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/08/2025 |
| 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="3"
Months="10"
Days="15" |
|
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
|
Oral submucous fibrosis is a Premalignant condition Satisfactory treatment is unavailable Trial drug is Haridradi Taila Malahar and Control drug is Daruharidra Rasakriya these Ayurvedic medicines to be locally used as a Pratisaran for Oral submucous fibrosis Both experimental and control groups are studied respectively Observation and conclusions are drawn from statistical test for significance |