| CTRI Number |
CTRI/2024/07/069725 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Unani formulation (Sharbat-e-Toot Siyah) in Warm-e-Halaq Muzmin(Chronic Pharyngitis) patients |
|
Scientific Title of Study
|
Comparative clinical evaluation of Sharbat-e-Toot Siyah and its sugarfree dosage form in the management of Warm-e-Halaq Muzmin (Chronic Pharyngitis) |
| Trial Acronym |
WHM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Quba Naaz |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
8700567537 |
| Fax |
|
| Email |
quba.naaz456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shazia Jilani |
| Designation |
Associate Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
9718764154 |
| Fax |
|
| Email |
shaziajilani@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Azhar Jabin |
| Designation |
Associate Professor |
| Affiliation |
jamia hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
9899315252 |
| Fax |
|
| Email |
ajabin@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard, New Delhi- 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Hamdard Nagar, New Delhi 110062 |
| 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 Quba Naaz |
Majeedia Unani Hospital |
OPD/IPD of Moalajat and Ain, Uzn, Anf wa Halaq, Majeedia Unani Hospital, Jamia Hamdard University, Hamdard Nagar, New Delhi 110062
New Delhi
DELHI |
8700567537
quba.naaz456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethical Committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J312||Chronic pharyngitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sharbat-e-Toot Siyah |
25ml of Sharbat-e-Toot Siyah will be given orally twice a day for 6 weeks |
| Intervention |
Sharbat-e-Toot Siyah (Sugar free) |
25ml of sugar free Sharbat-e-Toot Siyah will be given orally twice a day for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed patients of chronic pharyngitis (Pharyngitis more than 3 months) presenting with all OR more than three of the following signs and symptoms
Sore throat
Dysphagia
Foreign body sensation
Burning sensation
Cough
Hoarseness of voice
Pharyngeal itching
Posterior pharyngeal wall hypertrophy
oedema
redness
|
|
| ExclusionCriteria |
| Details |
1) Age below 18 and above 65 years
2) Pregnant and lactating women
3) Congenital malformations of oropharynx
4) Diabetes mellitus
5) Oral candidiasis
6) Unwilling to participate in the study
7) Epiglottitis, Thyroiditis
8) Retropharyngeal abscess/peritonsillar abscess
9) Dental Sepsis
10) Carcinoma of throat
11) History of previous use of corrosives
12) Pts with Chronic liver, kidney or heart disease
13) Pts suffering from psychiatric disorders
14) History of seizures, severe HTN
15) Pts having carcinoma and terminal illness
16) Pts taking antibiotics for the current illness for last one week
17) Pts on regular steroid inhalers: MDI (Metered Dose Inhalers)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in Subjective Parameters i.e. symptoms to be assessed on Visual Analogue Scale (0 to 100 mm)
Sore throat
Dysphagia
Foreign body sensation
Burning sensation
Cough
Hoarseness of voice
Pharyngeal itching
2. Improvement in Objective Parameters i.e. PHARYNGOSCOPY will be used to analyse the signs of Chronic Pharyngitis [Grading on Likert Scale (4 point)] on following Pharyngeal Signs
Hypertrophy
Oedema
Redness
|
Baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life (QoL) |
0 & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="71" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 pharyngitis is a common disease in the otolaryngology field. It is characterized by diffuse chronic inflammation of the pharyngeal mucosa, submucosa, and lymphoid tissue and is also a part of chronic inflammation of the upper respiratory tract. Upper respiratory tract lesions adjacent to the pharynx, climate and regional environmental changes, occupational factors, systemic factors, and allergic factors can also cause the disease. About one-third of the patients in the otolaryngology clinic suffered from chronic pharyngitis. Pharyngitis (Warm-e-Halaq) is an inflammation of Ghisha-e-mukhati (mucous membrane) of Halaq (Pharynx). Warm-e-Halaq is also known as Dard Gale Voizeen (Clergyman Throat) as it usually occurs in Lecturer, Musicians and the people who use the throat beyond the limits like singing and shouting (excessive use of voice). Chronic Pharyngitis occurs in a result of recurrent or Prolonged Acute Pharyngitis. Study entitled, Comparative clinical evaluation of Sharbat-e-Toot Siyah and its sugar-free dosage form in the management of Warm-e-Halaq Muzmin (Chronic Pharyngitis) will be undertaken in the Department of Moalajat, SUMER, Jamia Hamdard, New Delhi. This will be a hospital-based, prospective, randomized, comparative, controlled clinical study. 56 patients will be randomly allocated in test group A and controlled group B with 28 patients in each group. Trial duration is 6 weeks.
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