| CTRI Number |
CTRI/2025/07/092121 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the Effect of a Herbal Syrup (Sharbat Ustukhuddus) on Long-Term Sinus Problems |
|
Scientific Title of Study
|
To Evaluate the Efficacy of Sharbat-e-Ustukhuddus in the management of Waram Tajawif al-Anf Muzmin (Chronic Rhinosinusitis): An open label interventional clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Salman |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Amraz-e- Ain Uzn Anf Halaq wa Asnan State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9457801887 |
| Fax |
|
| Email |
msalmanmintorian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Asif Hussain Usmani |
| Designation |
Professor |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Amraz-e- Ain Uzn Anf Halaq wa Asnan State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7905831926 |
| Fax |
|
| Email |
asifhussainusmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Salman |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Department of Amraz-e- Ain Uzn Anf Halaq wa Asnan State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9457801887 |
| Fax |
|
| Email |
msalmanmintorian@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj |
| Address |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin Code 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 Mohd Salman |
State Unani Medical College and HAHRDM Hospital |
Department of Amraz-e- Ain Uzn Anf Halaq wa Asnan State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016
Allahabad
UTTAR PRADESH |
09457801887
msalmanmintorian@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: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sharbat Ustukhuddus |
Patients will be given Sharbat Ustukhuddus 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 Mild to Moderate case of Chronic Rhinosinusitis
2 Duration of the disease More Than 12 weeks
3 Patient having at least two out of four cardinal symptom (facial pain/pressure, hyposmia or anosmia, nasal obstruction, and nasal discharge for at least 12 consecutive weeks
4 Patient having any of the following symptoms like rhinorrhea, nasal congestion, frontal headache, nasal itching, impaired sense of smell and frequent sneezing for more than 12 weeks
5 X-ray PNS with Positive finding (Thickened mucosal lining, opacity of sinus) |
|
| ExclusionCriteria |
| Details |
1 Patient aged less than 18years or more than 50years.
2 Patient with deviated nasal septum (DNS).
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 or Cardiovascular or Hepatorenal Dysfunction.
7 Patient not willing to attend regular treatment and follow-up for the entire duration of study.
8 Patient having history of any surgery of nose or paranasal sinuses.
9 Patient having history of trauma to nose or sinus area.
10 Patient of pulmonary Koch’s or having history of epistaxis.
11 Any medical condition where physician feels that participation in the study could be detrimental to patient’s wellbeing. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale(VAS)
SNOT-22:CRSspecificQoL |
2nd, 4th, and 6th Week from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
X-RAY (PNS)- Water’s View
AEC(Absolute Eosinophil Count) |
2nd, 4th, and 6th Week from baseline. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/08/2025 |
| 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 Yet Recruiting |
| 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
|
Chronic Rhinosinusitis) is defined as a group of disorders characterized by inflammation of paranasal mucosa and it is due to various aetiologies. Since inflammation of sinuses nearly always involves the nasal mucosa. Rhinosinusitis is now generally preferred term for this condition. Rhinosinusitis is a significant health problem which seems to the mirror the increasing frequency of allergic rhinitis and is an umbrella covering multiple disease entities, including acute Sinusitis, chronic Sinusitis with nasal polyps and chronic Sinusitis without polyps. Chronic Rhinosinusitis affects approximately 15% of the general population .The National Institute of Allergy and Infectious Diseases (NIAID) estimates 134 million Indians suffer from Chronic rhinosinusitis. 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 one of the most common reason for an individual seeking medical care. Medical management of Chronic Rhinosinusitis often require combining multiple medications including antibiotics, nasal decongestant, topical nasal steroid or oral steroids and saline irrigation. There are several single as well as compound Unani drugs which are in use for centuries for effectively treating Chronic Rhinosinusitis but many of them have not been evaluated clinically on scientific parameters further, the limitations of management of Chronic Rhinosinusitis available in modern medicine necessitate a scientific search for safe, effective and convenient medications for the disease. Keeping this in view, the present study is designed to evaluate the efficacy of Sharbat Ustukhuddus in case of Chronic Rhinosinusitis.
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