To Asses efficacy and safety of polyherbal unani formulation In Nazla

Phase 2/3

Not yet recruiting

Conditions: Allergic rhinitis, unspecified,

Registration Number: CTRI/2023/10/058727

Lead Sponsor: State Unani Medical College Himmatganj Prayagraj

Brief Summary: Allergic rhinitis (AR) is a significant public health, medical, and economic problem in developing

countries and AR is also an important risk factor for many diseases and disorders. The incidence of

AR has been on the rise in recent years and has a significant impact on the general public. This large

increase is alarming, and it is important to better understand the prevalence status and

characteristics, sensitization patterns, and associated risk factors for AR in order to improve

treatment and develop effective prevention strategies. It emphasizes the urgent need for

understanding

. The study highlights the rising trend of allergic rhinitis and its impact on children

and adults simultaneously which in turn demand more focused studies to prevent allergic rhinitis.

In another study conducted on Indian rural population also pointed out the challenge to

otorhinolaryngologist even having facilities of advance treatment and diagnostic facilities in order

to treat the patients of allergic rhinitis

. In the modern medical treatment numerous medications is

available. However, Self-medication is widespread and leads to both over- and under-medication.

Over medication is associated with numerous side effects that lead to unnecessary costs and

increased morbidity, while under medication leads to suboptimal symptom control that

compromises quality of life . The most effective treatment is intranasal corticosteroids till date

.

Commonly available INCS are beclomethasone, triamcinolone, budesonide, fluticasone,

mometasone, and ciclesonide. INCS has been shown to improve nasal congestion and reduce sleep

disturbance and daytime sleepiness in patients. It aims to improve the quality of life during the day,

reduce fatigue and ultimately improve childrenâ€™s school performance. However, dry nose, crusting

of mucous membranes, and bleeding are not uncommon. Other side effects of INCS include

transient symptoms such as nasal stinging, throat irritation, and even perforation of the nasal septum.

When it comes to the treatment of allergic rhinitis- It is a well-known fact that Continuous use of

anti-allergy and anti-inflammatory drugs always has many dangerous side effects. In order to

provide comprehensive approach to treat allergic rhinitis, Unani medicine, an alternative form of

treatment, comes forward with successful management of diseases and numerous historical

evidences available about the efficacy of Unani medicine in Nazla Haar (allegic rhinitis). These

drugs can be used for a long time without side effects. The Unani system offers a large number of

single and combination n drugs that can be administered to populations of different temperaments.

Keeping the above facts in view, it has been planned to conduct a clinical trial entitled "EVALUATION OF EFFICACY AND SAFETY OF POLYHERBAL UNANI

FORMULATION IN NAZLA HAAR (ALLERGIC RHINITIS)".

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patient of any sex 2.
Age group between 19 to 50 years 3.
Patients clinically diagnosed with Nazla Haar(Allergic Rhinitis).
Patients with raised Total Eosinophil Count and Total Serum IgE.

Exclusion Criteria

Age below 19 years and above 50 years.
Pregnancy and Lactation.
Patients with history of Comorbidities like Diabetes and Hypertension, Renal impairment, etc.
4.Patients with other disease of Nose.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The level of Absolute Eosinophil Count and Non specific Serum IgE will be assessed by analysing the blood samples and result will be subjected to statistical analysis using paired t test.	Baseline, 1 and 2 weeks
2.The Total Nasal Symptoms Score (TNSS) will be used to assess the sum of score of the following symptoms, Nasal Congestion, Sneezing, Nasal itching, and Rhinorhoea at each time point, using four point scale (0-3).	Baseline, 1 and 2 weeks

Secondary Outcome Measures

Name	Time	Method
Other Allergic disorders like skin allergy may be assessed	0 and 3 weeks

Trial Locations

Locations (1): OPD/IPD of Amraze Ain Uzn Anf Halaq wa Asnan,
🇮🇳
Allahabad, UTTAR PRADESH, India
OPD/IPD of Amraze Ain Uzn Anf Halaq wa Asnan,
🇮🇳Allahabad, UTTAR PRADESH, India
Dr Zeba Khan Warsi
Principal investigator
8630020478
amberkhanwarsi@gmail.com