Study to evaluate the additional benefit of Vachadi Kashay gargle along with Azithromycin in treating acute tonsillitis in children aged 6 12 years

Randomized Controlled Trial to evaluate the add on effect of Vachadi Kashay Kawal with Azithromycin in management of Tundikeri with reference to Acute Tonsillitis in children of age group 6-12years - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108654

Enrollment

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J039- Acute tonsillitis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients presenting with clinical signs and symptoms of Tundikeri (Acute Tonsillitis) such as: Shotha (tonsillar enlargement) Raga (redness) Ruk (pain) Galoparodha (difficulty in swallowing) 2)Children of age group 6 12 years. 3)Patients of either gender. 4)Patients whose parents/guardians give written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients with complications like: Peritonsillar abscess Tonsillar cyst Tonsillolith Patients suffering from systemic illnesses such as: HIV, Tuberculosis, Hepatitis B 2)Patients requiring surgical intervention (e.g., tonsillectomy). 3)Known cases of drug allergy to Azithromycin or trial drug.

Design outcomes

Primary

Measure	Time frame
Change in severity of signs and symptoms of Tundikeri (Acute Tonsillitis) including Tonsillar swelling (Shotha) Throat pain (Ruka) Congestion (Ragatwa) Difficulty in swallowing (Galoparodha) Assessed using a standardized grading scaleTimepoint: 5 days	—

Secondary

Measure	Time frame
1)Overall clinical improvement Categorized as complete, marked, moderate, mild, or unchanged based on percentage relief in symptoms Time taken for symptomatic relief Number of days required for reduction in throat pain, swelling, and dysphagia Comparison of efficacy between groups 2)Difference in improvement between trial group (Vachadi Kashay Kawal + Azithromycin) and control group (Azithromycin alone) Requirement of rescue medication (if any) Incidence of adverse drug reactions (ADR) Safety assessment of both interventionsTimepoint: 5 days	—

Measure

Time frame

1)Overall clinical improvement Categorized as complete, marked, moderate, mild, or unchanged based on percentage relief in symptoms Time taken for symptomatic relief Number of days required for reduction in throat pain, swelling, and dysphagia Comparison of efficacy between groups 2)Difference in improvement between trial group (Vachadi Kashay Kawal + Azithromycin) and control group (Azithromycin alone) Requirement of rescue medication (if any) Incidence of adverse drug reactions (ADR) Safety assessment of both interventionsTimepoint: 5 days

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Countries

India

Contacts

Public ContactDr Ravindra Dhanwade

PMT Ayurved College Shevgoan

dhanwaderavi7@gmail.com7620055444

Outcome results