FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
Close