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Clinical Trials/CTRI/2025/08/092456
CTRI/2025/08/092456Not yet recruitingPhase 2/3

To evaluate the efficacy of polyherbal unani formulations in the management of waram i halaq muzmin (chronic pharyngitis) an open label single arm study

State Unani Medical College and HAHRDM Hospital1 site in 1 country44 target enrollmentStarted: August 20, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
44
Locations
1
Primary Endpoint
Visual Analogue Scale (VAS)

Study Overview

Brief Summary

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.Virusis 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 Siyah2 tola(24mL) orally twice daily for 42 Days.Follow-up will be done 7 14 21 28 35 and 42 days from baseline.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

Time Frame: 7, 14, 21, 28, 35 and 42 days from baseline

Secondary Outcomes

  • Reduction in Absolute Eosinophil count and within normal limit of CBC.

Investigators

Sponsor
State Unani Medical College and HAHRDM Hospital
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Mashhood Nasir

State unani medical college and HAHRDM hospital

Study Sites (1)

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