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CTRI Number  CTRI/2024/10/075936 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Management of sinusitis with the help of aromatherapy 
Scientific Title of Study   An observational study on Chronic Sinusitis (Waram-tajaweef al-anf muzmin) and theurapetic evaluation of aromatherapy (shamoom) in its management  
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 Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology. Department: Centre for AYUSH Sciences Division: Ayush health and wellness centre, OPD no:1

Pulwama
JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Division: Ayush health and wellness centre, OPD no:1


JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology. Department: Centre for AYUSH Sciences,Division: Ayush health and wellness centre, OPD no:1


JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Source of Monetary or Material Support  
Islamic University of Science and Technology, Awantipora, Pulwama, Jammu & Kashmir. 192122.India 
 
Primary Sponsor  
Name  Islamic University of Science and technology 
Address  Islamic University of Science and Technology, Awantipora, Pulwama 192122, Jammu & Kashmir. 
Type of Sponsor  Research institution 
 
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 Tabasum Fatima  AYUSH Health and Wellness Centre  Islamic University of Scienec and technology, Department-Centre for AYUSH Science, Ayush Health and Wellness Centre, Moalijat OPD, Room no 1.
Pulwama
JAMMU & KASHMIR 
9419421375

tabasumfatima281@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Islamic University of Science and technology  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  polyherbal formulation comprising of Pudina (Menthaspicata L.), Ajwain(PtychotisAjowan), Ustukhudus (Prunella Vulgaris), Marzanjosh (OriganumMajorana) and Guletesu (Butea Frondosa)   the drugs will be added in water and then steam inhalation will be given at bed time for 15 minutes daily for 45 days with follow up as on the 15th, 30th,45th day. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed patients of Sinusitis with headache, nasal obstruction, running nose, malaise, hyposmia
2.Irrespective of all genders.
3.Patient’s between15-60 years of age.
 
 
ExclusionCriteria 
Details  1.Patients below 15 and above 60 years of age.
2.Pregnant and Lactating mothers.
3.Patients who fail to give consent.
4.Patients with history of Cardiovascular, Endocrine, Renal and Liver diseases
5.Patients with COPD, Asthma and any severe lung disease
6.Pregnancy, Lactation, Patients on Oral Contraceptives.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
X- Ray Para nasal Sinuses  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
SNOT 22  2 years 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/11/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tabasumfatim281@gmail.com].

  6. For how long will this data be available start date provided 05-07-2025 and end date provided 07-07-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

WaramTajäwéf al-AnfMuzmin (Chronic Sinusitis) is the chronic inflammation of para nasal sinuses which affects all people worldwide.Symptoms and signs of NazlaBäridMuzmin have been described in details in of Unani literature which closely resemble the symptoms of chronic sinusitis, although IltihäbTajäwéf al-Anf or WaramTajäwéf al-Anf (Sinusitis) has not been mentioned as a disease in literature of Unani Medicine.(1,2,3,4) Therefore, NazlaBäridMuzmin has been considered as WaramTajäwéf al-AnfMuzmin (Chronic Sinusitis). WaramTajäwéf al-AnfMuzminis 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 sometimes is caused by dental infection, deeply seated in upper jaw. Most of the times, the maxillary sinuses are involved. However, it may also affect other sinuses on one or both sides.(5,6,7)Chronic sinusitis is characterized by symptoms of sinusinflammation lasting more than 12 weeks. This illness is mostcommonly associated with either bacteria or fungi, and clinicalcure in most cases is very difficult.28 In this stage, the damageto the mucus membrane occurs which leads to the impairmentof the ciliary activity and thickening of mucus membrane. Thiscondition may progress until the sinus is filled with polypi andpus, which is discharged at frequent intervals into the nose.Symptoms are varied and complaint may be of frequent colds,or an unpleasant taste or a bad smell in the nose. The discharge is frequently foul. As the condition settles into the chronic stage, pain and tenderness disappear The treatment of choice for chronic sinusitis in conventional medicine is nasal or oral corticosteroids, antibiotics, nasal sprays, decongestants. The drugs are associated with various side effects like nose bleeds, stinging sensation in the throat and nose, in rare cases nasal perforation can also occur due to use of nasal corticosteroids. Therefore a polyherbal formulation comprising of Pudina (Menthaspicata L.), Ajwain(PtychotisAjowan), Ustukhudus (Prunella Vulgaris), Marzanjosh (OriganumMajorana) and Guletesu (Butea Frondosa) will be given as inhalation or Shamoom to the patients and efficacy will be tested.

Study design: Open observational study.

 

 

Sample size: 20 patients.

 

Intervention.

 

Test drugs:Pudina, Ajwain, Ustukhuddus, Marzanjosh, GuleTesu.

 

Method of Prepration:

 

Dosage: 5 gm of each drug taken in 200ml of water and boiled and shamoom or inhalation taken daily at bed time for ten minutes.

 

Route of Administration: Inhalation

 

Duration   of Protocol: 45 days with follow up as ( 15th, 30th,45th)

 

Duration of Study: 2 years

 

Procedure of study:

Enrolled cases of Sinusitis will be taken, after obtaining a written informed consent. The patients will be treated with test drugs and pre and post treatment subjective and objective findings (effects) will be compared and its significance will be evaluated through a suitable statistical test.

 
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