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CTRI Number  CTRI/2019/04/018778 [Registered on: 25/04/2019] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “A Clinical Study to see the effectiveness of Guda-Haritaki (Jaggery with Terminalia Chebula fruit) in Kaphaja Pratishaya (Allergic Rhinitis) in children” 
Scientific Title of Study   A Randomized Controlled Clinical Study on the efficacy of Guda-Haritaki in Kaphaja Pratishaya with special reference to Allergic Rhinitis in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amol Sheshrao Patil 
Designation  Assistant Professor 
Affiliation  Shri Gurudeo Ayurved Mahavidyalaya, Gurukunj Ashram, Tq. Teosa, Dist. Amravati Pin code. 444902 
Address  Shri Gurudeo Ayurved Mahavidyalaya, Gurukunj Ashram, Tq. Teosa, Dist. Amravati Pin code. 444902
Shri Gurudeo Ayurved Mahavidyalaya, Gurukunj Ashram, Tq. Teosa, Dist. Amravati Pin code. 444902
Amravati
MAHARASHTRA
444902
India 
Phone  9604539549  
Fax    
Email  dramoltpty@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dattatray Bhaurao Chavan 
Designation  Associate Professor 
Affiliation  Government Ayurved College nanded 
Address  Dr Dattatray Bhaurao Chavan Near Mahatma Phule School Ganesh Nagar Nanded

Nanded
MAHARASHTRA
431602
India 
Phone  9422174644  
Fax    
Email  drdbchavan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amol Sheshrao Patil 
Designation  Assistant Professor 
Affiliation  Shri Gurudeo Ayurved Mahavidyalaya, Gurukunj Ashram, Tq. Teosa, Dist. Amravati Pin code. 444902 
Address  Shri Gurudeo Ayurved Mahavidyalaya, Gurukunj Ashram, Tq. Teosa, Dist. Amravati Pin code. 444902
Shri Gurudeo Ayurved Mahavidyalaya, Gurukunj Ashram, Tq. Teosa, Dist. Amravati Pin code. 444902
Amravati
MAHARASHTRA
444902
India 
Phone  9604539549  
Fax    
Email  dramoltpty@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital, Nanded, University of Health Science, Nashik, Maharashtra 
 
Primary Sponsor  
Name  Dattatray Chavan 
Address  Government Ayurvedic college Nanded  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Dattatray B Chavan  Government Ayurvedic College and Hospital, Nanded, Maharashtra  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Amol Sheshrao Patil  Government Ayurvedic College and Hospital, Nanded, Maharashtra.  Government Ayurvedic College and Hospital, Nanded, Maharashtra.
Nanded
MAHARASHTRA 		 9604539549

dramoltpty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurvedic College, Vazirabad, Nanded, Maharashtra.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J310||Chronic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral administration of Study drug (Guda-Haritaki) and control drug (Guda-Shunthi).  Study drug (Haritaki) and control drug (Shunthi) will be administered with equal quantity of Guda. 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. 
Comparator Agent  Sunthi (Zinziber Officinale)   Sunthi (Zinziber Officinale) Dose- 1 to 3 gm in adult this dose will be converted according to Clarks Rule25 for children and will be use in the study by considering weight of children. The dose will be given for two times i.e. morning and evening after food. Duration of study is 28 days and route of administration is oral. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.

To evaluate the effect on change in eosinophils in nasal smear, serum IgE concentration and Absolute eosinophil count (AEC) at 28th day. 		 28th day. 
 
Secondary Outcome  
Outcome  TimePoints 
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.  		 14th day, 28th day and on 45th day. 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
Final Enrollment numbers achieved (Total)= "197"
Final Enrollment numbers achieved (India)="197" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/05/2019 
Date of Study Completion (India) 21/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. Dr. Amol S. Patil, Dr. Dattatray B. Chavan, Role Of Jaggery (Gud / Gur) In Children Diet: An Ayurveda Review. Wjpmr, 2022, 8(2), 167-169 2. Dr. Amol Sheshrao Patil, Dr. Dattatraya B. Chavan, Dr. Vijaykumar Gawai, Traditional Descriptions on Haritaki and its Therapeutic Importance: A Scientific Review, Ejbps, 2022, Volume 9, issue 3, 102-105. 3. Dr Amol Sheshrao Patil, Dr Dattatraya B. Chavan, Dr Vijaykumar Gawai, Ayurveda and Modern View on Pratishyaya W.S.R. to Preventive and Therapeutic Measures, International Journal of AYUSH, 2022; 11(1); 14-22.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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.

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.

 
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