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Clinical Trials/CTRI/2024/09/073459
CTRI/2024/09/073459
Not yet recruiting
Phase 2/3

A Clinical Study of Nazla Harr (Allergic Rhinitis) to Evaluate the Efficacy of Lauq Rumman in its Management

State Unani Medical College and HAHRDM Hospital1 site in 1 country40 target enrollmentStarted: September 12, 2024Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
State Unani Medical College and HAHRDM Hospital
Enrollment
40
Locations
1
Primary Endpoint
1. Changes in Total Nasal Symptom Score (TNSS) and

Overview

Brief Summary

Allergic Rhinitis is an IgE mediated immunologic response of nasal mucosa to airborne allergens and is characterized by watery nasal discharge, nasal obstruction, sneezing and itching in the nose. This may also be associated with symptoms of itching in the eyes, palate and pharynx. It is estimated that AR currently affects up to 40% of the worldwide population, and high prevalence is being recorded in developed countries. Worldwide prevalence is sharply rising as more nations adopt western lifestyles. AR is thought to affect 500 million individuals worldwide, with the second decade of life seeing the highest occurrence. In India, reported incidence ranges between 20% and 30% with increasing prevalence over past few years.

According to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines, AR management encompasses allergen avoidance, pharmacotherapy (including intranasal corticosteroid and new second generation oral H1 antihistamines), immunotherapy and patient education. These treatments frequently have unfavorable side effects, are not always cost effective, and do not always completely relieve symptoms. Anaphylactic reactions, either local or systemic, can also result after immunotherapy.

Although AR is often considered a benign condition, it negatively impacts the quality of life (QOL) of affected individuals by impairing sleep quality and cognitive function, behavior, work performance and causing irritability, fatigue and anxiety with economic costs. Annual direct medical costs of AR are substantial, but indirect costs associated with lost work productivity are greater than those incurred by asthma.

Therefore, a safe and long--term effective treatment modality for AR is needed to provide symptom relief, decrease frequency and severity of AR recurrence and prevent the condition from progressing.

In Unani medicine, Allergic Rhinitis is treated by using Oral medicines (such as Behidana, Unnab, Sapistan, Banafsha, Kishneez, Asl--us--soos, Katira, Khatmi, Gaozaban etc.), Is’haal, Roghaniyaat either alone or in combination with Hijamat, Fasd, Qai’, Inkebab, Ghargharah, Takmeed, Nutool and Pashoya. Pharmacological studies suggest that these drugs contain pectins, mucilage, flavonoids, scopoletin, codein, polyphenols and possess anti--inflammatory, bronchodilator, anti--allergic, astringent, demulcent, expectorant, mild laxative, anti--tussive and immuno modulatory activity.

Therefore, a clinical trial entitled “A Clinical Study of Nazla Hārr (Allergic Rhinitis) To Evaluate the Efficacy of La„ūq Rummān in It‟s management” is contemplated to evaluate the efficacy of La‘ūq Rummān with the objective of improvement in symptoms and quality of life of the sufferers of Allergic Rhinitis.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age between 18 50 years
  • Both gender
  • 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.

Exclusion Criteria

  • Patients suffering from systemic illness like Hypertension, DM, Malignancy, Liver or Kidney dysfunction
  • Patients suffering from congenital nasal abnormalities like nasal dermoid cysts, congenital midline nasal masses, Deviated Nasal Septum, Atrophic rhinitis, Sinusitis, Hypertrophic turbinates, Adenoidal hypertrophy, foreign bodies or Asthma
  • Patients below 18 and above 50 years
  • Patients with past history of nose surgery
  • Patients had received systematically administered corticosteroids, antihistamines, decongestants or CAM therapy within 02 weeks prior to enrolment
  • Pregnant and lactating women.

Outcomes

Primary Outcomes

1. Changes in Total Nasal Symptom Score (TNSS) and

Time Frame: Day 7, 14 and 21.

2. Allergic Rhinitis Control Test (ARCT)

Time Frame: Day 7, 14 and 21.

Secondary Outcomes

  • 1. Improvement in Mini Rhino conjunctivitis Quality of Life Questionnaire (Mini RQLQ)(2. AEC( Absolute Eosinophilc Count ))

Investigators

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

Muzammil Husain

State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh.

Study Sites (1)

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