| 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
|
|
|
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
|
|
|
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. |