A Study Protocol On The Efficacy Of Fluticasone Versus Bharangi (Clerodendrom Serratum Linn) Arka (Aqueous Extract) (Preprint)
Authors: Balakrishnan Dr Deepthi 
Published: February 2024

BACKGROUND

•	Being the most common disease among school-going children, the choice of this disease
in Kaumarabrithya is to be justified.
•	In this study, the drug Bharangi (Clerodendrom serratum Linn) has been selected due to
its potent anti-allergic, anti-asthmatic and anti-inflammatory, antioxidant properties due
to the presence of icosahydropicenicacid, ursolic acid, saponins, steroids, flavonoids,
phenolics, etc. Also, the single drug formulation, in its distilled form is used in treating
Pratishyaya.
•	Nasal drug delivery can be considered the most effective mean to enhance the
bioavailability of the drug as it increases the retention time.

•	Since Nasya (errhine therapy) is contraindicated in children and a method of noninvasive
drug delivery is desirable, the use of a nasal spray can be found effective, and hence
chosen.
•	As the medicine is to be administered to children, the Nasal Spray is a simpler method.
•	The use of a nasal spray can also be justified considering that it is cost-effective.

OBJECTIVE

1.To evaluate the Clinical Efficacy of Bharangi Arka and its Efficacy on AEC in the management of Pratishyaya (Chronic Allergic rhinitis).
2. To evaluate the Clinical Efficacy of Fluticasone and its Efficacy on AEC in the management of Pratishyaya (Chronic Allergic rhinitis)
3. To compare the Clinical Efficacy of both Fluticasone and Bharangi Arka in the management of Pratishyaya (Chronic Allergic rhinitis)

METHODS

Study Type: Interventional.
Study Design: Randomized double-blind, Standard Controlled Comparative Equivalence Clinical Study. A minimum of 84 diagnosed children of Pratishyaya fulfilling inclusion criteria will be randomly selected and divided into two groups.
Randomization Method of selection of comparator: Computer generated Random Number Table method will be used to avoid bias in the study. Blinding and allocation concealment: Double blinding by covering both Nasal Spray bottles with a thick cloth sticking and coding by a third person.
Study setting:
This experimental study is to be carried out in the Outpatient and Inpatient Departments of Kaumarabhritya, Mahatma Gandhi Ayurveda College and Hospital Ward.
Sample size calculation:
The minimum sample size is determined by a formula,
n=2((z_1-α/2+z_1-β)/δ_0 )^2 xpx( 1-p)
Where,
????0: margin that is clinically acceptable
p: Response rate of standard treatment group
????: Significance level
1 − ????: Power
For getting an estimator for sample size n, we assumed that p=0.7 and ????0 = 3.44. Then for a fixed level of significant ???? = 0.05, and power 1 − ???? = 0.90 the estimated sample size is, ???? = 37.258. If the dropout rate d is 10%, final sample size N is obtained as N=n/(1-d). That is, N = 41.47.This is then rounded to 42. Hence, the number of samples needed per group is 42.

RESULTS

A total of 84 children belonging to the age group 4-14 years affected with Pratishyaya satisfying inclusion criteria will be selected and divided into Two groups such that each group will have 42 members. One of the groups will be given Fluticasone Nasal Spray and the other will be given Bharangi Arka Nasal Spray for 28 days. The drug for each group will be selected using double blinded method and named as Group M and Group N respectively based on the drugs administered. The assessments will be done on 1st, 7th ,14th,21st and 28th day depending on the criteria and the results in each group are compared to achieve the objectives proposed.

CONCLUSIONS

Studies have been conducted on the internal administration of Bharangi Arka showing significant results in Pratishyaya. Even as a single drug formulation it could provide more opportunities to explore the field of Ayurveda in the treatment of Pratishyaya. A study using cost-effective Bharangi could be an initiation for developments in formulations involving more than one drug. Also, it can show how effective is Bharangi Arka Nasal Spray when we have Fluticasone Nasal Spray, the widely used remedy for Rhinitis on the other side.

CLINICALTRIAL

CTRI2022/06/043408