Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

A randomized, double-blind, placebo-controlled study to evaluate the benefits of a standardized Nigella sativa oil containing 5% thymoquinone in reducing the symptoms of seasonal allergy.

  • 2024-08-01
  • Medicine 103(32)
    • Anju Majeed
    • Shaheen Majeed
    • Avinash Kadasiddappa Parameswarappa
    • Avinash Murali
    • Satish Gudimallam
    • Chikkalingaiah Siddegowda
    • Harshith Chandrashekar
    • Lakshmi Mundkur

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 65
Population
65 participants aged 18 to 60 years having 2 or more allergic symptoms like sneezing, rhinorrhoea, nasal obstruction, and nasal itching for a cumulative period greater than 1 hour per day
Methods
Randomized, double-blind, placebo-controlled study; participants received a capsule of NSO (250 mg) with 2.5 mg piperine (BioPerine) or a placebo, twice a day, after food for 15 days
Blinding
Double-blind
Duration
15 days
Funding
Unclear

Background

Allergic rhinitis (AR) or seasonal allergy characterized by sneezing, nasal congestion, nasal itching, and nasal discharge, triggered by immune reactions to environmental allergens. Present day customers also monitor the personal improvements in the area of Evidence-Based natural medicines/supplements.

Methods

A randomized, double-blind, placebo-controlled study was conducted on 65 participants aged 18 to 60 years having 2 or more allergic symptoms like sneezing, rhinorrhoea, nasal obstruction, and nasal itching for a cumulative period greater than 1 hour per day. The study participants received a capsule of NSO (250 mg) with 2.5 mg piperine (BioPerine) as a bioavailability enhancer or a placebo, twice a day, after food for 15 days. The primary objectives were evaluated by mean change in Total Nasal Symptom Score and the duration of AR symptoms per day from baseline to Day 15. Secondary endpoints were changes in Total Ocular Symptoms Score, AR symptom frequency and severity, serum Immunoglobulin E levels, and Patient Global Impression of Change scale. Adverse events were monitored throughout the study.

Results

Sixty-five patients were enrolled and all of them completed the study, N = 33 in NSO and N = 32 in placebo. A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo, highlighting the potential of NSO in alleviating AR symptoms. The episodes of AR symptoms per day and the frequency of symptoms in 24 hours reduced significantly in 15 days in both groups, but the extent of improvement was significantly higher in NSO compared to placebo. Improvement in Patient Global Impression of Change was also significantly better in NSO compared to the placebo. Serum Immunoglobulin E levels decreased in NSO but were not significantly different from placebo. No clinically significant changes were observed in vital signs, liver and renal function, lipid profile, hematology, fasting blood sugar, or urine analysis at the end of the study.

Conclusion

The result of the study demonstrates that NSO 250 mg with 2.5 mg piperine is an effective and well-tolerated supplement for the management of AR symptoms.

Research Insights

  • Black Cumin→Reduced Allergic Rhinitis Symptom Episode Per Day

    The episodes of AR symptoms per day and the frequency of symptoms in 24 hours reduced significantly in 15 days in both groups, but the extent of improvement was significantly higher in NSO compared to placebo.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2.5 mg twice a day
  • Black Cumin→Reduced Ocular Symptom Score

    A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2.5 mg twice a day
  • Black Cumin→Reduced Total Nasal Symptom Score

    A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2.5 mg twice a day
  • Black Pepper→Reduced Allergic Rhinitis Symptom Episode Per Day

    The episodes of AR symptoms per day and the frequency of symptoms in 24 hours reduced significantly in 15 days in both groups, but the extent of improvement was significantly higher in NSO compared to placebo.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2.5 mg twice a day
  • Black Pepper→Reduced Ocular Symptom Score

    A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2.5 mg twice a day
  • Black Pepper→Reduced Total Nasal Symptom Score

    A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo

    Effect
    Beneficial
    Effect size
    Small
    Dose
    2.5 mg twice a day
Back to top