A Study to Examine the Effects of Two Ayurvedic Formulations in the Treatment of Hay Fever: Allergy Rakshak Avaleha Alone and Allergy Rakshak Avaleha Combined with Allergy Rakshak Ghee

Effectiveness of Allergy Rakshak Avaleha alone and combination with Allergy Rakshak Ghee in managing allergic rhinitis: An open label randomized controlled study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067447

Enrollment

240

Registered

2024-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Allergic rhinitis patients of both genders, aged between 18 and 65 years at the time of enrollment Presence of 2 or more nasal symptoms (sneezing, watery rhinorrhea, nasal congestion, and nasal itching) Total Nasal Symptom Score (TNSS) greater or equal to 2 (TNSS is calculated by adding scores for each nasal symptom on a four-point scale (0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms, 3 means severe symptoms), with a maximum TNSS of 12)

Exclusion criteria

Exclusion criteria: Patients with deviated nasal septum, nasal polyps, or any clinically significant nasal anomaly Presence of upper respiratory tract infections or severe asthma, impaired hepatic and renal functions, abnormal cardiovascular or cerebrovascular conditions, or anemia, or a history of known systemic disorders Currently or previously treated for malignancy Undergoing steroid therapy Already receiving medications for allergic rhinitis or receiving antihistamines Known allergies to investigational products or their ingredients Pregnant or lactating mothers Any other individuals deemed unsuitable for inclusion by the investigators

Design outcomes

Primary

Measure	Time frame
Changes in Total Nasal Symptom Score (TNSS), serum IgE levels, and eosinophil countTimepoint: TNSS: 28 days and after 1 month of follow up; Serum IgE levels and eosinophil count: 28 days	—

Secondary

Measure	Time frame
Health-related quality of life (HRQoL)Timepoint: 28 days and after 1 month of follow up	—

Countries

India

Contacts

Public ContactDr Varun

Arogyam Ayurvedic Allergy Hospital, Jalandhar, Punjab

manager.arogyam@gmail.com9878235154

Outcome results