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CTRI Number  CTRI/2025/08/092456 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Effect of unani herbal medicines in chronic throat inflammation 
Scientific Title of Study   To evaluate the efficacy of polyherbal unani formulations in the management of waram i halaq muzmin (chronic pharyngitis) an open label single arm 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  Mashhood Nasir 
Designation  PG Scholar 
Affiliation  State unani medical college and HAHRDM hospital 
Address  Department of Amraz e ain uzn anf halq wa asnan state unani medical college and HAHRDM hospital himmatganj prayagraj
Himmatganj prayagraj
Allahabad
UTTAR PRADESH
211016
India 
Phone  9045958275  
Fax    
Email  mashhoodnasir@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrUsamah Ahmad 
Designation  Reader 
Affiliation  State unani medical college and HAHRDM hospital 
Address  Department of Amraz e ain uzn anf halq wa asnan state unani medical college and HAHRDM hospital himmatganj prayagraj
Himmatganj prayagraj
Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  arogyaherbal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mashhood Nasir 
Designation  PG Scholar 
Affiliation  State unani medical college and HAHRDM hospital 
Address  Department of Amraz e ain uzn anf halq wa asnan state unani medical college and HAHRDM hospital himmatganj prayagraj
Himmatganj prayagraj
Allahabad
UTTAR PRADESH
211016
India 
Phone  9045958275  
Fax    
Email  mashhoodnasir@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh 211016 
 
Primary Sponsor  
Name  State Unani Medical College and HAHRDM Hospital  
Address  State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh 211016 
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 Mashhood Nasir  State Unani Medical College and HAHRDM Hospital  Department of Amraz e Ain Uzn Anf Halq wa Asnan State Unani Medical College Himmatganj Prayagraj 211016
Allahabad
UTTAR PRADESH 
9045958275

mashhoodnasir@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J312||Chronic pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  decoction of Mako Khushk 7gm Gul e Banafsha 7gm Unnab 5pieces Sapistan 9 pieces with Sharbat toot siyah  60mL Joshanda (decoction) with 2 tola (24 ml) Sharbat Toot Siyah twice daily for 42 days. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Participants of either gender in the age group of 18-65 years
2 Participants clinically diagnosed with Waram i Halq Muzmin (Chronic pharyngitis)
3 Based on symptoms (sore throat pharyngeal itching or dry throat) and signs (pharyngeal oedema congestion of pharyngeal mucosa or pharyngeal statis of secretion) persist more than 3 weeks.
 
 
ExclusionCriteria 
Details  1 Pregnant and lactating women.
2 Known case of renal,hepatic,cardiac ailments and diabetes malitus.
3 Those had taken antibiotic and other medications against chronic pharyngitis in the past 15 days.
4 Chronic pharyngitis with complication.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS)  7, 14, 21, 28, 35 and 42 days from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Absolute Eosinophil count and within normal limit of CBC.
 
7, 14, 21, 28, 35 and 42 days from baseline 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   20/08/2025 
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 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
Modification(s)  

Pharyngitis is defined as mucosal inflammation of the oropharynx, hypopharynx, adenoids, and tonsils. Pharyngitis arises from upper respiratory tract infections and can be categorized as acute or chronic. Acute pharyngitis may manifest as catarrhal purulent or ulcerative depending on the causative agent and the individual s immune response
Chronic pharyngitis can present as catarrhal hypertrophic, or atrophic. It is an chronic inflammatory condition of the pharynx characterized by the hypertrophy of mucosa, seromucinous glands subepithelial lymphoid follicles and potentially even the muscular layer of the pharynx.
Virus is the most common cause of acute pharyngitis. Approximately 10 percent of adults are affected by Streptococcal pharyngitis. Other less common causes include certain bacteria (such as gonorrhea) fungi irritants like smoke and allergens as well as gastroesophageal reflux disease. Chronic pharyngitis can have various underlying causes i.e. persistent sore throat despite completing a course of antibiotics it is advisable to seek additional medical guidance. Recent studies such as the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey have documented about 5  million visits to primary care physician s clinics and emergency departments annually for adult with chronic pharyngitis. Chronic pharyngitis often signals an underlying issue and relieving it involves addressing the root cause. To alleviate the sore throat individuals can gargle with warm saline solutions maintain proper hydration refrain from smoking and manage pain with over the counter medications like acetaminophen/paracetamol.But Acetaminophen can induce various side effects including hypersensitivity reactions nephrotoxicity and anemia. Additionally it may rarely precipitate severe adverse effects such as anaphylactic reactions. Fortunately our Unani system of medicine offers very effective and safe treatments for Pharyngitis. In classical Unani literature Chronic Pharyngitis is referred to as Waram i Halq muzmina, characterized by inflammation of the Ghisha-i-mukhati (mucous membrane) of the Halq (Pharynx). The Unani system provides a wealth of single and compound drugs for managing Chronic Pharyngitis many of which have been utilized for an extended period without reported side effects such as Khyar Shambhar (Cassia fistula L.) Banafsha (Viola odorata L.) Milk of Fig and Tukhm e Hulba (Trigonella foenum) etc. Taking into account this context, there arises a necessity to explore alternative herbal medicines for treating Waram i Halq. With this in mind the present study has been undertaken after an exhaustive and meticulous review of classical Unani literature encompassing signs and symptoms clinical examination and medical management strategies. Participants will be given decoction of Unani single drug consisting of  Mako Khushk (7gm)  Gul-i-Banafsha (7gm)  Unnab (5 pieces approx 6gm) Sapistan (9 pieces approx 5gm) with Sharbat  Toot Siyah 2 tola(24mL) orally twice daily for 42 Days.Follow-up will be done 7 14 21 28 35 and 42 days from baseline.

 
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