Effectiveness of selected Ayurveda management protocol in adenoid hypertrophy among children of age group 5 to 10 years.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr. Musafar Ahammed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- To assess the effect of Varanadi Kashaya, Kanchanara guggulu tablet, Vilwadi tablet
Overview
Brief Summary
Adenoid hypertrophy is a condition characterized by obstruction of airway in the
nasopharyngeal region by the enlarged adenoids. Adenoids gets
hypertrophied with/without acute or chronic infection of the adenoid, obstructing the posterior nasal
opening and respiratory, nasal and aural symptoms are shown. Even though the hypertrophy gets
atrophied during puberty, it can create serious difficulties to the individual in the form of upper airway
obstruction associated with, nasal block, mouth breathing, obstructive sleep apnea, hypopnea, and
upper airway resistance syndrome (UARS) etc. At present Adenoidectomy is the only definite
management available for Adenoid hypertrophy, which can cause aftereffects like recurrent respiratory
infections and allergic reactions. Chances of regrowth is also up to 26% and recurrence of some
symptoms are also reported in many cases. No conservative managements are available at present. So,
an alternate management protocol is a necessity.The selected treatment protocol includes Varanadi
Kashaya, Kanchanara guggulu tablet, Vilwadi tablet, Trikatukadi gandusham for one month followed
by 1 month of pathyakala with Saptamushtika yusha panam which has kaphahara properties. 23
patients diagnosed with non-infectious adenoid hypertrophy of age group 5-10 years selected on the
basis of inclusion criteria attending OPD and IPD of Shalakyatantra, Govt. Ayurveda College,
Thiruvananthapuram will be subjected to the selected treatment protocol for 30 days followed by 1
month of pathya. Clinical evaluation will be done prior to the commencement of intervention, 15th day,
30th day and 60th day. Results will be statistically analyzed after the study by Kruskal-wallis test.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed cases of adenoid hypertrophy with breathing difficulty.
- •Patients between age group 5 years to 10 years, irrespective of gender, religion, and socio-economic status.
Exclusion Criteria
- •Diagnosed cases of systemic disorders like renal and cardiac diseases Diagnosed cases malignancy, TB, anemia and bleeding disorders.
- •Use of corticosteroids in all forms within 3 months of enrolment Participants with Infectious adenoid hypertrophy.
- •Malnourished and underweight children.
- •Children with developmental delay.
Outcomes
Primary Outcomes
To assess the effect of Varanadi Kashaya, Kanchanara guggulu tablet, Vilwadi tablet
Time Frame: 0th,30th,60th day
and Trikatukadi gandusha followed by Saptamushtika yusha pana and pathyahara and
Time Frame: 0th,30th,60th day
vihara in reducing the symptoms in participants of age group of 5-10 years irrespective
Time Frame: 0th,30th,60th day
of gender diagnosed with adenoid hypertrophy.
Time Frame: 0th,30th,60th day
Secondary Outcomes
- To critically study adenoid hypertrophy in an Ayurvedic perspective.(0th,15th,30th, 60th day)
Investigators
Dr Musafar Ahammed
Government Ayurveda Medical College thiruvananthapuram kerala