Comparing the effect of two Ayurveda drugs on the treatment of allergic rhinitis

• Register: ISRCTN
• Last refreshed on: 17 August 2020
• Main ID: ISRCTN18149439
• Date of registration: 02/05/2019
• Prospective Registration: Yes
• Primary sponsor: University of Colombo
• Public title: Comparing the effect of two Ayurveda drugs on the treatment of allergic rhinitis
• Scientific title: Development of an Ayurvedic pharmaceutical preparation for allergic rhinitis and evaluation of its safety and efficacy
• Date of first enrolment: 30/05/2019
• Target sample size: 210
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN18149439
• Study type: Interventional
• Study design: Three-arm open-label non-inferiority randomized control clinical trial (Treatment)
• Phase: Phase II

Countries of recruitment

Sri Lanka

Contacts

• Name: Jeevani Dahanayake

• Name: Pathirage Kamal Perera

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age 18-65 years at the time of enrollment, of either sex
2. No known systemic disorders
3. Newly diagnosed allergic rhinitis patients on Ayurvedic treatment
4. No history of drug allergy
5. Non-pregnant and non-breastfeeding
6. Have given written informed consent to participate in this study
7. Total Nasal Symptom Score (TNSS) more than 6

Exclusion criteria:
1. Patients with deviated nasal septum/nasal polyps/nasal growth/adenoids/asthma
2. Patients with impaired liver and kidney functions, anaemia, and unstable cardiovascular conditions or cerebrovascular conditions
3. Currently or previously treated for any malignancy
4. Patients on steroid therapy
5. Already on treatment with herbal decoction or antihistamines
6. Pregnant or lactating mothers
7. Illiterate patients without a literate relative/guardian who can explain the procedures and maintain the patient diary


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Allergic rhinitis
Respiratory
Allergic rhinitis, unspecified

Intervention(s)

This will be a three-arm open-label non-inferiority randomized control trial in patients with allergic rhinitis. Consecutive consenting sample method will be followed to select participants of the arms for the study. A blocked design will be used, using an online statistical computing web programming to generate the randomization schedule (research randomizer https://www.randomizer.org). Eligible subjects will be randomly assigned to Arm I, Arm II and Arm III to receive herbal decoction, freeze-dried powder of herbal decoction and antihistamine for 28 days.

The patients of Arm I will be treated with herbal decoction (Tamalakyadi decoction), 120 ml twice a day after meals. Arm II patients will be treated with 6 g of freeze-dried powder of herbal decoction. The powder should be dissolved in 240 ml of hot water and should take 120 ml twice a day after meals. The patients of Arm III will receive antihistamine (loratidine 10 mg) at night taken with 240 ml of water. Patients belong to three arms have to visit the clinic weekly.

Total Nasal Symptom Score (TNSS) and IgE level of patients will be the primary efficacy endpoints. The mean difference in TNSS and IgE level will be compared between the three arms as the primary endpoints at the end of 28 days. The TNSS will be again analyzed after 1 month and 2 months of treatment at follow-up visits.

Mean score of daytime nasal symptoms, nighttime nasal symptom, non-nasal symptoms and Health-Related Quality of Life score will be used as secondary endpoints in the clinical trial. These symptom scores will be analyzed by using the information mentioned in rhinitis diary card of the patient. This diary cards will be collected weekly at the clinic.

Foll

Primary Outcome(s)

1. Nasal symptoms (watery rhinorrhea, sneezing, nasal obstruction, nasal itching) measured using the Total Nasal Symptom Score (TNSS) of allergic rhinitis patients at baseline and the end of intervention (after four weeks, after one month of follow up and two months of follow up)
2. Serum Immunoglobulin E level measured using chemiluminesent enzyme immunoassay (EIA) at baseline and after intervention

Secondary Outcome(s)

1. Mean score of daytime nasal symptom score
2. Mean score of nighttime nasal symptom score
3. Mean score of non-nasal symptoms
Patient self-rated symptom scores (daily rhinitis diary card) and allergic rhinitis grading symptoms collected on a weekly basis during the assessment period. The measurement of symptoms on a 4-point rating scale with the following definition will be used:
• 0 = absent symptoms (no sign/symptom evident)
• 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated)
• 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable)
• 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping)
4. Health-related quality of life measured using HRQoL questionnaire (Valero et al, 2009 & 2013) at baseline and end of intervention (after four weeks, one month of follow up and two months of follow up)

Secondary ID(s)

2016/Mphil-PhD/029

Nil known

Source(s) of Monetary Support

University Grants Commission - Sri Lanka

Ethics review

Status:
Approval date:
Contact:

Approved 22/01/2019, Ethics Review Committee (Institute of Indigenous Medicine, University of Colombo, Rajagiriya, Sri Lanka; Tel: [phone]; Email: [e-mail]), ref: ERC 18/76

Results

• Results available: Yes
• Date Completed: 01/05/2021