| CTRI Number |
CTRI/2025/08/093407 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Effectiveness of Traditional Unani Herbal Medicines in Treating Oral Submucous Fibrosis |
|
Scientific Title of Study
|
TO EVALUATE THE EFFICACY OF
POLYHERBAL UNANI FORMULATIONS IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS OPEN
LABEL INTERVENTIONAL CLINICAL TRIAL
MANAGEMENT OF ORAL SUB-MUCOUS FIBROSIS OPEN LABEL INTERVENTIONAL CLINICAL TRIAL |
| Trial Acronym |
OSMF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alisha Adil |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical college and HAHRDM hospital |
| Address |
Department of Amraz e Ain Uzn Anf Halq wa Asnan state unani medical college and HAHRDM Hospital himmatganj prayagraj Himmatganj Prayagraj Allahabad UTTAR PRADESH 211016 India |
| Phone |
8373948493 |
| Fax |
|
| Email |
alishaadil1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Abdul Quddus |
| Designation |
LECTURER |
| Affiliation |
State Unani Medical college and HAHRDM hospital |
| Address |
Department of Amraz e Ain Uzn Anf Halq wa Asnan state unani medical college and HAHRDM Hospital himmatganj prayagraj Himmatganj Prayagraj Allahabad UTTAR PRADESH 211016 India |
| Phone |
6395496007 |
| Fax |
|
| Email |
dr.yalamlam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Alisha Adil |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical college and HAHRDM hospital |
| Address |
Department of Amraz e Ain Uzn Anf Halq wa Asnan state unani medical college and HAHRDM Hospital himmatganj prayagraj Himmatganj Prayagraj Allahabad UTTAR PRADESH 211016 India |
| Phone |
8373948493 |
| Fax |
|
| Email |
alishaadil1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and HAHRDM Hospital himmatganj Prayagraj 211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and HAHRDM hospital |
| Address |
Himmatganj Prayagraj Uttar Prades 211016 |
| 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 Alisha Adil |
State Unani Medical College and HAHRDM Hospital |
Department of Amraze Ain Uzn Anf Halq wa Asnan
State Unani Medical College himmatganj Prayagraj Uttar Pradesh PIN code 211016
Allahabad
UTTAR PRADESH Allahabad UTTAR PRADESH |
8373948493
alishaadil1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) for biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khamira Banafsha and Barg i Rehan sabz |
20 grams Khamira Banafsha twice daily after meal with normal water for 12 weeks.
5 to 6 gm fresh leaves of Rehan by chewing per day for 12 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patients having clinical signs and symptoms of OSMF with a documented history of consuming chewing tobacco areca nut pan masala or gutka as the primary etiological factor scoring 6 or below based on the classification given by SK Katharia37
The patients willing to give written informed consent to do protocol follow up |
|
| ExclusionCriteria |
| Details |
Extensive fibrosis and or with severe trismus with an Inter Incisal Distance less than or equal to 17mm
Disease is most advanced with known malignant changes
Patients on any treatment for OSMF In case they are then such a treatment would be stopped and a washout period of 2 weeks would be given
Pale oral mucosa of anemia mimicking blanching
Pregnancy lactation Chronic debilitating conditions such as DM HTN HIV Hepatitis B bleeding disorders cardiovascular diseases renal dysfunction liver disorders mucosal disease or any other skin lesions and a known allergy or contraindication to the study drug
Patients not willing to give up addiction habits of Gutka Pan Masala tobacco |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
LIKERT scale
VAS scale |
0 3 6 9 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IID Inter Incisal Distance |
0 3 6 9 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="43" Sample Size from India="43"
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)
|
01/09/2025 |
| 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 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 Sub Mucous Fibrosis is a chronic condition of the oral cavity characterized by inflammation and fibrosis in the mucosa and submucosa leading to mouth rigidity and difficulty opening the mouth Symptoms include a burning sensation intolerance to spicy foods ulcers and loss of taste The primary cause is the habitual chewing of areca nut betel nut often combined with tobacco though other factors like excessive spice consumption smoking and genetic predisposition also contribute
OSMF has a high morbidity rate due to eating difficulties and nutritional deficiencies and it can lead to oral cancer often progressing from lesions like leukoplakia or OSMF itself In India approximately twenty three point nine percent of the adult population consumes areca nut with a high prevalence of oral malignancies linked to this habit
Current treatment includes nutritional support physiotherapy steroids and surgical interventions though these are often limited in effectiveness and have side effects There is growing interest in herbal treatments with a focus on Khamira Banafsha and Barg i Rehan Sabz in Unani medicine as potential alternatives for managing OSMF Despite existing treatments recurrence remains common highlighting the need for more effective and holistic solutions Hence this study is planned with a holistic Unani approach to evaluate the efficacy of Khamira banafsha and Barg i Rehan sabz in the management of OSMF |