A pilot study to evaluate the efficacy of saline extract of jackfruit seeds (JaSE) for the treatment of rhinitis and nasal congestion related ailments
Introduction – Jackfruit Seeds
Jacalin is a lectin protein extracted from jackfruit seeds, known for its ability to bind specific sugar molecules, especially those found on glycoproteins. It has gained importance in medical research due to its role in identifying cancer cells and viruses like HIV by targeting specific carbohydrate structures. Jacalin also shows immune-boosting properties and is used to study immune cell responses. Its natural origin and unique binding abilities make it useful in diagnostics and therapeutic research.
- Lectins from jackfruit seeds- Jacalin and ArtinM
- Jacalin and artinM have immunomodulatory and antimicrobial activity
- Jacalin stimulate CD4+ T cells, activates macrophages, has a specific affinity for sIgA, has potent anticancer activity
- ArtinM induces neutrophil migration, interleukin-12 production, and Th1 cell-mediated immunity
- Jackfruit seed extract and a combination of jacalin & artinM had shown a cumulative protective effect
BKL Walawalkar Hospital, Dervan
IEC Approval
Institutional Ethics Committee approval for A pilot study to evaluate the efficacy of saline extract of jackfruit seeds for the treatment of rhinitis and nasal congestion related ailments
Preview Document
SVJCT’S JaSE Nasal Drops
- Ingredients :- Jackfruit Seed Extract, Normal Saline.
- Application :- Use 2 drops per nostril, thrice daily for 15 days.
- Usage :- Allergic Rhinitis, Headache, Cough, Cold, Sore throat.
Rational of the study
- Immunomodulatory lectins (jacalin and artinM) in jackfruit seed extract speculates its role in treating rhinitis
- Ayurveda (Bhavprakash Nighantu) reports the property of jackfruit seed as an expectorant of mucus promoting secretion and/or expulsion of mucus
- Ayurvedic literature (Charaka Samhita) suggests the efficacy and safety of nasal ingestion of jackfruit seed extract
- Locals also promote the consumption of jackfruit seeds due to the wide range of health benefits of jackfruit seeds
- In-lab studies revealed presence of active jacalin and artinM in the saline extract of jackfruit seeds
- Hence, we propose to use saline extract of jackfruit seeds (JaSE) as a nasal spray to cure rhinitis and other nasal congestion related ailments
Hypothesis
JaSE will act as an immunomodulator. It will help in treating rhinitis and nasal congestion related ailments. This will improve the quality of life of patients. As jackfruit is widely available in rural India, it will provide a local product-based solution to the community.
Primary objective
- To evaluate the efficacy of JaSE in relieving rhinitis and other nasal congestion symptoms
Secondary objectives
- Correlation of laboratory measurements of immune response with clinical outcomes.
Study methodology
- Single blind, single center, double arm, pilot study
- Eligible patients will be included in the study and will be treated with either JaSE or saline (control group)
- JaSE will be prepared by an Ayurvedic doctor from locally available jackfruit seeds
- Day 1 – Enrollment, assessment (clinical observations by treating doctor), sample collection, training of patients regarding procedure of administration and storage of drops (JaSE or Saline)
- Day 15 – Second sample collection and clinical observations
- Day 30 – Routine clinical follow-up
- Clinical assessment by observing nasal obstruction score, CBC, ESR, CRP, sIgA, CD4 T-cells, and Visual Mucosal Evaluation on the 1st and 15th day of starting the treatment
Inclusion exclusion criteria
Inclusion Criteria
- Fitness to participate in the trial
- Informed consent with a willingness to follow up for clinical and laboratory studies
- Age above 18 years
Exclusion Criteria
- No co-morbidities (Diabetes, malignancies, hyperthyroidism)
Statistical methods used / interpretation of data
Nasal obstruction score and changes in clinical investigations pre and post treatment will be recorded. The independent t-test will be used to compare mean values between the 2 groups pre and post treatments. The repeated measured analysis of variance (ANOVA) will be used to analyze the changes in the mean values from baseline to 15th day of treatment. A p-value of less than 0.05 will be considered to indicate statistical significance.
Expected Outcome
Local product-based solution (JaSE) will improve nasal mucosal immunity and thereby may cause symptomatic relief from rhinitis and other nasal congestion ailments.
