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CTRI Number  CTRI/2023/04/051601 [Registered on: 13/04/2023] Trial Registered Prospectively
Last Modified On: 11/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   clinical comparative study of unani drug in chronic rhinosinusitis 
Scientific Title of Study   A Clinical Study of Waram-e-Tajaweef-e-Anf Muzmin” (Chronic Rhinosinusitis) and the Comparative Evaluation of Sharbat-e-Banafsha and Joshandha Gaozaban in its Management 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Tariq 
Designation  PG Scholar 
Affiliation  state Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India, Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  9927188397  
Fax    
Email  mohammadtariq49580@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Asif Hussain Usmani 
Designation  Professor HoD  
Affiliation  state Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India, Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usamah Ahmad 
Designation  associate professor 
Affiliation  state Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India, Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  arogyaherbal@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College, Prayagraj, Ministry of Ayush, govt. of Uttar pradesh 
 
Primary Sponsor  
Name  State Unani Medical College Prayagraj 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India, Allahabad UTTAR PRADESH 211016 India 
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 
Mohammad Tariq  State Unani Medical College and HAHRDM Hospital   OPD/IPD Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH 
9927188397

mohammadtariq49580@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Joshandha Gaozaban(oral)  Joshandha Gaozaban will be given 45ml twice a day for the 6 weeks. 
Intervention  Sharbat-e-Banafsha (oral)  Sharbat-e-Banafsha will be given in the dose of 25 ml twice a day orally for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients fulfilling AAO-HNS criteria that is at least two major criteria
(Nasal obstruction or blockage, anterior or posterior nasal discharge, Facial pain /congestion, Purulence in a nasal cavity on examination, Anosmia/ Hyposmia) or one major and two minor criteria (Halitosis, earache, dental pain, cough, fatigue)
2 patients had an opacity of X-ray paranasal sinuses (waters view) ranging from +1 (Mucosal thickening) to +3 (complete opaque antrum) grading.
3 Patients of either sex.
4 Patients in the age group of 18 to 60 years.
5 Patients with involvement of any sinus.
6 Those who give written consent.
 
 
ExclusionCriteria 
Details  1 Child below 18 years of age.
2 Patients above 60 years of age.
3 Pregnant & lactating mothers.
4 Patients who fail to give consent.
5 Patients who fail to follow up.
6 Mentally retarded persons.
7 Patients with Malignancy of the nose or paranasal sinuses.
8 Patients have a history of any surgery of the nose or paranasal sinuses.
9 Patients have a history of any foreign body in their nose.
3Patient have a history of trauma to the nose or sinus areas.
10 Patients suffering from any congenital or acquired structural abnormality of the nasal cavity.

11 Any medical condition where the physician feels that participation in the study could be detrimental to patientsÂ’ wellbeing.
12 Patients of pulmonary Kochs or patients having history of epistaxis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 reduction in AAO-HNS criteria
2 reduction in X-ray paranasal sinuses (waters view) ranging from +1 (Mucosal thickening) to +3 (complete opaque antrum) grading. 
0 and 6 week 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in clinical features  0 and 6 week 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/04/2023 
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)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The term sinusitis is replaced by rhinosinusitis because sinusitis is often preceded by rhinitis and rarely occurs without concurrent nasal airway inflammation. Thus, the refers to inflammation of the mucosal lining of nose and paranasal sinuses. Chronic rhinosinusitis is very common condition and has been estimated to affect approximately 5-15% of general population. It is often very frustrating and difficult to treat therefore many patients have undergone with repeated courses of antibiotics, long term use of oral or topical steroids and multiple sinus surgeries increasing their risk of colonization with antibiotic resistant agent, various side effects of steroids and of surgical complications. Approximately 200000 U.S adult undergo sinus surgery per year for chronic rhinosinusitis, most commonly because of failing medical therapyAs far as economic impact is concerned, CRS accounts for substantial healthcare expenditure in terms of doctor’s visits, antibiotic prescribed, lost work days and missed school days. In unani literature there is no specific description of Waram-e-Tajaweef-e-Anf Muzmin (chronic rhinosinusitis) but the features described by unani physicians under nazla barid and nazla muzmin in various books corresponds with signs and symptoms of sinusitis.

Unani system of medicine provides abundance of single and compound drugs which can be given in nazla barid for longer duration without any known side effect.

The goal of the research work is to provide economical, effective and consecutive management of chronic rhinosinusitis and to protect the patient from known side effects of modern medicine. Moreover, to achieve and maintain clinical control, avoid complications and to minimize the surgical requirement by using two different Unani formulations Sharbat-e-Banafsha and Joshandha Gaozaban (Gaozaban Gul-e-gaozaban, Asl-us-soos Qand safed), two separate groups and also to compare their effects on relieving the symptoms of chronic rhinosinusitis 
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