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临床试验/CTRI/2025/08/092623
CTRI/2025/08/092623尚未招募2/3 期

To Evaluate The Efficacy of oral Unani formulation and Rogan Banafsha as Qatur-i-Anf(Nasal Drop) in Nazla Harr(Allergic Rhinitis):An Open Label Interventional Study

State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Serum IgE

研究概览

简要总结

The study titled To Evaluate the Efficacy of Oral Unani Formulation and Roghan Banafsha as Qatur i Anf Nasal Drop in Nazla Harr Allergic Rhinitis An Open Label Interventional Study aims to scientifically assess the effectiveness and safety of traditional Unani medicine in the management of allergic rhinitis. Allergic rhinitis referred to as Nazla Harr in Unani literature is an IgE mediated condition that presents with symptoms such as sneezing nasal congestion watery nasal discharge and itching. It is a widespread condition that significantly impacts the quality of life and work performance of affected individuals. Although modern medicine offers various treatment options these often come with side effects such as drowsiness and impaired psychomotor function.

In this open label single arm interventional trial 40 patients aged between 18 and 60 years with clinically diagnosed allergic rhinitis will be selected from the OPD of State Unani Medical College and HAHRDM Hospital Prayagraj. The intervention consists of a polyherbal Unani decoction Joshanda made from Gule Banafsha Unnab Sapistan Tukhm Khatmi and Misri administered orally along with Roghan Banafsha used as a nasal drop Qatur i Anf. The treatment will be given for three weeks with weekly follow ups followed by a post treatment assessment in the fourth week.

The study will evaluate efficacy based on subjective parameters like nasal discharge sneezing nasal congestion nasal itching and eye irritation and objective measures such as serum IgE levels and symptom severity scores. Safety will be monitored through clinical examination and laboratory investigations. This research is designed to validate the traditional Unani approach and offer a low cost accessible and safe alternative to conventional therapies for allergic rhinitis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Symptoms persisted for more than 4 days per week or more than 4 weeks per year and at least one of the following rhinitis-associated conditions: nasal congestion, rhinorrhea sneezing and nasal itching.
  • Patients who will give consent and able to do follow up.

排除标准

  • Patients below 18 and above 60 years.
  • Patients suffering from systemic illness like Hypertension, Diabetes Mellitus, Malignancy,Liver or kidney dysfunction.
  • Patients suffering from congenital nasal abnormalities like nasal dermoid cysts, Deviated Nasal Septum, Atrophic rhinitis, Sinusitis, Hypertrophic turbinates, Adenoidal hypertrophy, foreign bodies.
  • Patients had received systematically administered corticosteroids, antihistamines, decongestants or CAM therapy within 02 weeks prior to enrolment.
  • Pregnant and lactating women.

结局指标

主要结局

Serum IgE

时间窗: 7th,14th,21st day from baseline

Symptom Severity Score

时间窗: 7th,14th,21st day from baseline

次要结局

  • Japanese Rhino-conjunctivitis Quality of Life Questionnaire(7th,14th,21st,28th day from baseline)

研究者

发起方
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nurain Siddiqi

State Unani Medical College himmatganj Prayagraj Uttar Pradesh 211016

研究点 (1)

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