MedPath

Anti enuretic efficacy of Amrabeeja tablet and non pharmacological interventio

Phase 2
Conditions
Health Condition 1: N399- Disorder of urinary system, unspecified
Registration Number
CTRI/2024/04/065045
Lead Sponsor
All India Institute Of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Patients between 5 to 10 years of age of either sex.

2. Patient with the complaint of repeated involuntary voiding of urine into bed or clothes at night.

(According to DSM-V Criteria)

3. Parents of patients willing to give assent/consent for the trial.

Exclusion Criteria

1. Children with congenital anomalies, chronic ailments like tuberculosis, malignancy, cardiac, and renal disorders.

2. Children suffering from urinary tract infections, diabetes mellitus, worm infestation.

3. Children with the symptomatology of any syndrome.

4. Children with physical disabilities, structural abnormality of the genitourinary system.

5. Parents of the patient not willing to participate in the trial.

6. Any condition which the investigating team considers may jeopardize the participant’s health

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PART 1- 1. Phytoconstituent analysis of the Amrabeeja tablet. <br/ ><br>2. To search the docking and dynamics based predictive correlation of selected phytoconstituents of <br/ ><br>Amrabeeja with known targets of antidiuretic (Desmopressin). <br/ ><br>PART 2- <br/ ><br>Comparative analysis of Amrabeeja and Desmopressin on V2 receptor activity in Nocturnal <br/ ><br>Enuresis using cell line study. <br/ ><br>PART 3- <br/ ><br>Reduction in Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) in children with <br/ ><br>Shayyamutra (Nocturnal Enuresis) in 2 months.Timepoint: Baseline <br/ ><br>After 2 months of intervention <br/ ><br>After 2 months of follow up
Secondary Outcome Measures
NameTimeMethod
ilTimepoint: Nil
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