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CTRI Number  CTRI/2024/07/071703 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative effectiveness of Itrifal ustukhuddus and Sharbat e Sadar in the treatment of Chronic Sinusitis 
Scientific Title of Study   A clinical study of Waram Tajawif al -Anf Muzmin (chronic sinusitis) to evaluate the efficacy of ITRIFAL USTUKHUDDUS and SHARBAT E SADAR 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Farhat Jahan 
Designation  Post Graduate Scholar 
Affiliation  State Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College,Himmatganj Prayagraj 211016 Uttar pradesh India

Allahabad
UTTAR PRADESH
211016
India 
Phone  9927793406  
Fax    
Email  contact2farhat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Asif Hussain Usmani 
Designation  Head of Department and Professor 
Affiliation  State Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College,Himmatganj Prayagraj 211016 Uttar pradesh India

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Usamah Ahmad 
Designation  Reader 
Affiliation  State Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College,Himmatganj Prayagraj 211016 Uttar pradesh 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,U.P govt 211016 India  
 
Primary Sponsor  
Name  State Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College, Himmatganj Prayagraj 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 
Dr Farhat Jahan  State Unani Medical College and HAHRDM Hospital Prayagraj 211016 Allahabad Uttar Pradesh  OPD/IPD of Ain Uzn Anf Halaq wa Asnan
Allahabad
UTTAR PRADESH 		 9927793406

contact2farhat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
Intervention  Itrifal Ustukhuddus  Patients will be given compound test drug that has to be administered orally after meals in a dosage of 7gm for 6 weeks. 
Comparator Agent  Sharbat e Sadar  Pateints will be given Sharbat e Sadar in the dose of 20 ml twice a day for 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients of any sex, aged 18-50 years
2. Duration of the disease greater than 12 week.
3. Patient having at least two out of four cardinal symptoms i.e., facial pain/pressure,
hyposmia/anosmia, nasal obstruction, and nasal discharge for at least 12 consecutive
weeks
4. Patient having any of the following symptoms like rhinorrhoea, nasal congestion, frontal
headache, nasal itching, impaired sense of smell and frequent sneezing for more than 12
weeks.
5. Positive X-ray PNS finding like Thickened mucosal lining, opacity of sinus.
 
 
ExclusionCriteria 
Details  1. Patient aged below 18 years or above 50 years
2. Patient with deviated nasal septum
3. Local pathology such as mucocele, cyst, antrochoanal polyp, facial trauma.
4. Diabetes mellitus and any other illness requiring long term treatment.
5. Pregnant or Lactating Women.
6. Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
7. Known cases of Immunocompromised states like HIV/ AIDS, etc. or Malignancies
8. Patient not willing to attend regular treatment and follow-up for the entire duration of
study
9. Mentally retarded patients.
10. Patient having history of any surgery of nose or paranasal sinuses.
11. Patient having history of trauma to nose or sinus area.
12. Patient of pulmonary Koch’s or having history of epistaxis.
13. Any medical condition where physician feels that participation in the study could be
detrimental to patient’s well- being.
14. Alcoholic and Drug addicted patient. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical assessment will be done and the response to treatment will be
assessed using the following parameters:
1. Visual Analogue Scale 		 Week 2, 4 and 6. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Visual Analogue Scale  Week 2, 4 & 6. 
 
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)   12/08/2024 
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   Waram TajaÌ„wiÌ„f al-Anf Muzmin is called chronic sinusitis in modern medicine, which is a chronic inflammatory condition of upper respiratory tract involving the paranasal sinuses.It is usually followed by coryza and cold or sometime resultant of dental infection deeply seated in upper jaw. Inflammation of sinuses nearly always involves the nasal mucosa ‘Rhinosinusitis, is now generally preferred term for this condition. In Unani System of Medicine, there are some principles for nomenclature of disease. The disease is not named as “iltihab”, instead it is named as “Waram”. Therefore, iltihab meaning Sozish wa Lapat (burning and flame) has been described as a symptom of Nazla Harr not as a disease. Thus, the term Waram Tajawif al-Anaf is more appropriate for sinusitis. Chronic sinusitis affects approximately 14.7% of the general population.The National Institute of Allergy and Infectious Diseases (NIAID) estimates 134 million Indians suffer from chronic sinusitis. Among Indians the disease is more widespread than diabetes, asthma or coronary artery disease which results in a large financial burden on society. It is among the most typical causes for people to seek medical attention. Although sinusitis symptoms are not life-threatening, they are linked to a sharp decline in quality of life (QOL) and QOL scores equalize serious illness such as congestive heart failure, angina pectoris and chronic obstructive pulmonary disease. The term "chronic sinusitis" refers to an inflammatory condition affecting the Sino nasal mucosa that lasts for more than 12 weeks and is characterised by at least two of the following symptoms: nasal obstruction, blockage, or congestion, nasal discharge (anterior/posterior nasal drip), facial pain or pressure, loss of smell, coughing, and endoscopic disease signs or relevant CT scan changes. The etiopathogenesis of Chronic sinusitis continues to be the focus of much debate and research in the field of rhinology and remains controversial. Multifactorial factors altering the host- environment interaction such as bacteria, fungi, viruses, allergens, or environmental toxins may trigger the inflammatory process. Medical management of Chronic Sinusitis often require combining multiple medications including antibiotics, nasal decongestant, topical nasal steroid and / or oral steroids and saline irrigation. Side effects of, steroids antibiotics and decongestant are Cushing syndrome, steroid induce Diabetes, gastric ulcers, GI bleeding and avascular necrosis of femoral head, epistaxis, dry nose, burning nasal itching, pharyngitis, otitis, change of taste, eczema, nausea, diarrhoea, common cold, GI symptoms skin rashes reversible elevation of liver enzymes Patient who does not respond to full medical treatment alone requires surgical treatment with endoscopic sinus surgery. Potential development of microbial resistance remains a salutary concern in these patients due to repeated and prolong use of antibiotics. there is no solution for permanent relief and need an alternative approach which is safe and effective. The limitations of management of Chronic sinusitis available in modern medicine necessitate a scientific search for safe, efficient, and practical medications for the condition. There are numerous single as well as compound Unani drugs which have been used for centuries to treat Waram Tajawif al-Anf Muzmin, but many of them have not been evaluated clinically on scientific parameters. Keeping this in view, the present study is designed to evaluate the comparative efficacy of ITRIFAL USTUKHUDDUS and SHARBAT E SADAR in case of chronic sinusitis.  
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