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CTRI Number  CTRI/2026/01/100729 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 24/12/2025
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   A Study to Evaluate the Effect of a Polyherbal Unani Medicine and Sharbat e Toot Siyah in Patients with WARAM AL LAWZATAYN MUZMIN Chronic Tonsillitis 
Scientific Title of Study   COMPARATIVE EFFICACY OF A POLYHERBAL UNANI FORMULATION AND SHARBAT E TOOT SIYAH IN THE MAMAGEMENT OF WARAM AL LAWZATAYN MUZMIN CHRONIC TONSILLITIS A RANDOMIZED 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  Saara Naaz 
Designation  Research scholar  
Affiliation  State Unani medical College and hospital  
Address  Department of Amraz e Ain Uzn Anaf Halq Wa Asnan Himmatganj Allahabad

Allahabad
UTTAR PRADESH
211001
India 
Phone  7007341395  
Fax    
Email  sarahnaaz09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohd Asif Hussain Usmani 
Designation  Prof and HOD 
Affiliation  State Unani medical College and hospital  
Address  Department of Amraze e Ain Uzn Anaf Halq Wa Asnan Himmatganj Allahabad

Allahabad
UTTAR PRADESH
211001
India 
Phone  7007341395  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saara Naaz 
Designation  Research scholar  
Affiliation  State Unani medical College and hospital  
Address  Department of Amraze e Ain Uzn Anaf Halq Wa Asnan Himmatganj Allahabad

Allahabad
UTTAR PRADESH
211001
India 
Phone  7007341395  
Fax    
Email  sarahnaaz09@gmail.com  
 
Source of Monetary or Material Support  
State unani medicine college and hospital  
 
Primary Sponsor  
Name  State unani medicine college and hospital  
Address  OLD GT ROAD HIMMATGANJ PRAYAGRAJ 211016 
Type of Sponsor  Government medical college 
 
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 
Saara Naaz  State Unani Medical College  OPD No.06, Department of Amraze Ain Uzn Anf Halq Wa Asnan State Unani Medical College and Hospital
Allahabad
UTTAR PRADESH 		 7007341395

sarahnaaz09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Polyherbal Unani Formulation  Polyherbal Unani Formulation will be administered Joshanda orally at a dose of 30 mL twice daily for a period of 6 weeks. 
Comparator Agent  Sharbat-e-Toot Siyah  Sharbat-e-Toot Siyah will be administered orally at a dose of 20 mL twice daily for a period of 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  Patients of either gender in the age group of 18 to 39 years.

Clinically diagnosed cases of Waram al-Lawzatayn Muzmin chronic tonsillitis.

Disease severity with Clinical Scoring System
Severe equal or more than 9
Moderate 4 to 8
Mild equal or more than 3

Patients who will give consent and able to do follow up. 
 
ExclusionCriteria 
Details  Pregnant and lactating women.

Patient with any complication of tonsillitis.

Tonsillitis associated with any other systemic metabolic or chronic disease.

Patients unsure about attending schedule regularly.

Patients who have received any antibiotic therapy within the last 2 weeks will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in clinical scoring system.
Improvement in patient global assessment on visual analog scale (VAS). 		 At Baseline
2nd week
4th week
6th week 
 
Secondary Outcome  
Outcome  TimePoints 
Tonsillectomy Outcome Inventory 14
 		 At Baseline
6th week 
 
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 
Date of First Enrollment (India)   10/01/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [asifhussainusmani@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The term Lawzah originates from Arabic and refers to Gudud gland In modern medicine, the word tonsil derives from Latin, meaning swelling
Tonsils are clusters of lymphoid tissue located in the throat that play a key role in local immunity and serve as a first line of immune surveillance helping to prepare the entire body for defense The tonsils commonly referred to as the palatine or faucial tonsils which are situated in the tonsillar fossa between the palatoglossal and palatopharyngeal arches
Waram e Lawzatayn tonsillitis refers to the inflammation of the tonsils which may also extend to involve the adenoid and lingual tonsil
Chronic tonsillitis is defined as a condition in which a person experiences seven or more episodes of acute tonsillitis in a year
Tonsillitis is more commonly observed in school aged children though it can frequently occur in adults as well Key predisposing factors include poor nutrition and inadequate oral and dental hygiene The condition is most often caused by persistent or recurrent infections of the nose and paranasal sinuses which result in postnasal discharge that subsequently infects the tonsils Common symptoms include throat discomfort bad breath halitosis and an unpleasant taste in the mouth On physical examination the tonsils may appear enlarged and protrude beyond the tonsillar pillars Tonsillitis is rarely seen in infants and individuals over the age of 50
 
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