“A Clinical Study to see the effectiveness of Guda-Haritaki (Jaggery with Terminalia Chebula fruit) in Kaphaja Pratishaya (Allergic Rhinitis) in childrenâ€
- Conditions
- Chronic rhinitis,
- Registration Number
- CTRI/2019/04/018778
- Lead Sponsor
- Dattatray Chavan
- Brief Summary
This study is a prospective, open labelled, randomized, control clinical trial to see the efficacy of *Guda-Haritaki* in *Kaphaja Pratishaya* with special reference to Allergic Rhinitis in children.
Allergic Rhinitis is one of the most common allergic disease worldwide in children. In India, the prevalence of allergic rhinitis in children is 21.99% 1 and it increasing day by day due to change in life style.
Allergic Rhinitis correlates with *Ayurvedic* terminology i.e. *Kaphaja Pratishaya2*. In *Kashyap samhita*, *Guda-Haritaki* is recommended in the management of *Pratishyaya3*. One of the condition of *Pratishaya* which is having pathological background of allergy to respiratory mucosa is consider here as a disease condition here.
Studying the *Nidanas* (etiology)of *Pratishaya*, allergic conditions are due to the *Agni-mandhyakara Nidanas and Sntarpanotta Nidanas*, which is responsible for *Ammotpatti* at *Rasavaha Strotas* and *Pranavaha Strotas* leading to allergic condition of respiratory system.
By virtue of its properties *Haritaki* is consider as best *Sarva-Dosha Prashamana, Rukshana Dravya, Agni-Dipan Dravya, Annulomana Dravya*, and *Rasayana* Properties4*,*which can be utilize in the *Samprapti-Bhanga* (pathological correction) of *Agni* and *Amma* in the treatment of *Kaphaja* *Pratishaya* with special reference to Allergic Rhinitis in children.
The chemical constitutional components of *Haritaki* reduces the production of IgE5 and having anti-inflammatory6, Immuno-Modulatory7, Mast cell stabilizer8, Anti-anaphylactic9, Free Radical scavenger10 and potent Antioxidant10 properties. These properties will work for pathological correction of Allergic Rhinitis in children.
*Sunthi (Zinziber Officinale)* powder with *Guda* (jaggery) is control group11 medicine. *Puran* *Guda* (Jaggery) is used in study as an *Anupana* (drug vehicle) in both groups.
The dose of *Haritaki* is 3 to 6 gm in adult according to The Ayurvedic Pharmacopoeia of India12, for children dose will be converted according to Clark’s Rule13 and will be used in the study by considering weight of children.
For control group, the dose of *Shunthi* is 1 to 3 gm in adult according to The Ayurvedic Pharmacopoeia of India14, for children dose will be converted according to Clark’s Rule15 and will be use in the study by considering weight of children. Study drug and control drug will be administered with equal quantity of Guda16.The dose of intervention according to weight of the patient will be given for two times i.e. morning and evening after food.
Study drug and control drug will be administered orally for the duration of 28 days in 156 patients with Kaphaja Pratishaya with special reference to Allergic Rhinitis in children.
The Study will be conduct at Government Ayurvedic College, Vazirabad, Nanded, Maharashtra.
The Primary outcome measures will be all symptoms of Kaphaja Pratishaya (Allergic Rhinitis) (Nasal congestion, Nasal obstruction, Nasal itching, Clear Rhinorrhea, Sneezing and conjuntival irritation) reduced and change in eosinophils in nasal smear, serum IgE concentration and Absolute eosinophil count (AEC) at 28th day.
The Secondary outcome measures will be all symptoms of Kaphaja
Pratishaya (Allergic Rhinitis) (Nasal congestion, Nasal obstruction, Nasal itching, Clear Rhinorrhea, Sneezing and conjuntival irritation) reduced at 14th day and Quality of life in children with Kaphaja Pratishaya (Allergic Rhinitis) at 14th day, 28th day and 45th day will improved.
Considering above things, it is need of hour that, to see the role of *Haritaki* in *Kaphaja* *Pratishaya* with special reference to Allergic Rhinitis in children should be reviewed by its chemical action, to have an alarm for the scientific community, so the present review has planed.
References:-
1. Dara PK, Kumari P, Meena H, Sharma BS. Prevalence of various oculo-respiratory allergic conditions and their comorbid association: A cross-sectional observational study in children (6–18 years) from Jaipur. Indian J Allergy Asthma Immunol 2018;32: 15-9.
2. Ayurvedalankara Shrisatyapal Bhishagacharya, Pratishaya Chikitsadhyaya, Kashyapa Samhita Chikitsastan; Choukhambha Sanskurt Sanstan, Varanasi; Ninth Edition; 2004, page 132.
3. Ayurvedalankara Shrisatyapal Bhishagacharya, Pratishaya Chikitsadhyaya, Kashyapa Samhita Chikitsastan; Choukhambha Sanskurt Sanstan, Varanasi; Ninth Edition; 2004, page 132.
4. The Ayurvedic Pharmacopoeia of India; Ministry of the health and family welfare, department of Ayurveda, Yoga & naturopathy, Unani, Siddha and Homoeopathy(AYUSH) Government of India; Part I, Volume-I; First edition 2011, New Delhi; Page 48.
5. Ishrina Rubab & Shakir Ali (2016) Dried fruit extract of Terminalia chebula modulates the immune response in mice, Food and Agricultural Immunology, 27:1, 1-22, DOI:10.1080/09540105.2015.1055554. To link to this article: <https://doi.org/10.1080/09540105.2015.1055554>.
6. Siems W, Bresgen N, Brenke R, Siems R, Kitzing M, Harting H, Eckl PM. Pain and mobility improvement and MDA plasma levels in degenerative osteoarthritis, low back pain, and rheumatoid arthritis after infrared Airradiation. Acta Biochim Pol. 2010;57:313–9.
7. Vaibhav Aher and ArunKumar Wahi, Immunomodulatory Activity of Alcohol Extract of *Terminalia chebula* Retz Combretaceae, *Tropical Journal of Pharmaceutical Research*, 2011, 10 (5), 567-575.
8. Srivastava S and Choudhary GP: *In-vivo* and *In-viro* Mast Cell Stablizing Activity of Ethyl Acetate and Methanol Extarct of *Terminalia Chebula* Fruits: A Therapeutic Approach for Asthma. *Int J Pharmacognosy* 2016; 3(6): 246-50:.doi link: <http://dx.doi.org/10.13040/IJPSR.0975-8232.IJP.3(6).246-50>.
9. Shin TY, Jeong HG, kim DK, Kim SH, Lee JK, Chae BS, et al. Inhibitory action of water soluble fraction of Terminalia chebula on systematic and local anaphylaxis. J Ethnopharmacol 2001; 74: 133-140.
10. Abdulghani MA , Mohamed AH and Amina HAA (April 2015); Therapeutic and Immunologic Effects of *Zingiber officiale* in Allergic Rhinitis; DOI: 10.5772/59377; <https://www.researchgate.net/publication/300721580>; page 154-165.
11. Abdulghani MA , Mohamed AH and Amina HAA (April 2015); Therapeutic and Immunologic Effects of *Zingiber officiale* in Allergic Rhinitis; DOI: 10.5772/59377; <https://www.researchgate.net/publication/300721580>; page 154-165.
12. The Ayurvedic Pharmacopoeia of India; Ministry of the health and family welfare, department of Ayurveda, Yoga & naturopathy, Unani, Siddha and Homoeopathy(AYUSH) Government of India; Part I, Volume-I; First edition 2011, New Delhi; Page 48.
13. Laura A Drubach M D Laura A. Drubach M.D. Children’s Hospital Boston; Radiopharmaceutical Dosin g in Pediatrics; SNM 2009 Anuual Meeting; slid no8;[http://apps.snm.org/docs/CME/PresenterItems/EventID\_85 /PresenterItemTypeID\_1/2.%20Drubach%20-%20925.pdf](http://apps.snm.org/docs/CME/PresenterItems/EventID_85%20/PresenterItemTypeID_1/2.%20Drubach%20-%20925.pdf).
14. The Ayurvedic Pharmacopoeia of India ; Government of India, Ministry of the health and family welfare, department of Ayurveda, Yoga & naturopathy, Unani, Siddha and Homoeopathy(AYUSH) New Delhi; Sunthi; part I, Volume-I; First edition 2011,; Page 104.
15. Juniper, E.F., Howland, W.C., Roberts, N.B., Thompson, A.K., and King, D.R. Measuring quality of life in children with rhinoconjunctivitis. *J Allergy Clin Immunol*. 1998; 101: 163–170.
16. Tripathi B, Sarngadhara Samhita; Anukta Paribhasha Prathamo adhyaya; choukhambha Sanskrut Pratishtana; Re-print 2005; Shloka 50; page 17.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 156
- Children are with symptoms of Kaphaja Pratishaya (Allergic Rhinitis) of age 6 to 12 years1.
- Patients will be selected irrespective of sex and religion.
- Patients, whose parents are willing to participate their child in the study and are ready to sign informed consent form will be selected for the study.
- Children with symptoms of Allergic Rhinitis occur for > 4 days per week and / or for > 4 consecutive weeks at a time.
- The laboratory finding of increased numbers of eosinophils in the nasal mucosal smear (presence of > 4 % eosinophils for 6 to 10 years of age and >10 % eosinophils for 11 to 12 years of age) and elevated Total Serum IgE concentration (> 20 IU/ml)that patients will be selected.
- Patients with nasal abnormalities like D.N.S., Nasal polyps, adenoid and tonsilar hypertrophy.
- Patients with acute respiratory infection or severe concomitant disease (Tuberculosis, Pneumonia).
- Malnourished child.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect on change in eosinophils in nasal smear, serum IgE concentration and Absolute eosinophil count (AEC) at 28th day. 28th day. To evaluate the effect on change in symptoms (Nasal congestion, Nasal obstruction, Nasal itching, Clear Rhinorrhea, Sneezing and conjuntival irritation) of Allergic Rhinitis at 28th day. 28th day.
- Secondary Outcome Measures
Name Time Method To evaluate the effect on change in symptoms (Nasal congestion, Nasal obstruction, Nasal itching, Clear Rhinorrhea, Sneezing and conjuntival irritation) of Allergic Rhinitis at 14th day. Quality of life in children with Allergic Rhinitis at the first follows up visit i.e. at 14th day, 28th day and on 45th day.
Trial Locations
- Locations (1)
Government Ayurvedic College and Hospital, Nanded, Maharashtra.
🇮🇳Nanded, MAHARASHTRA, India
Government Ayurvedic College and Hospital, Nanded, Maharashtra.🇮🇳Nanded, MAHARASHTRA, IndiaAmol Sheshrao PatilPrincipal investigator9604539549dramoltpty@gmail.com