Anti enuretic efficacy of Amrabeeja tablet and non pharmacological intervention

Add on anti-enuretic efficacy of Amrabeeja tablet with non-pharmacological intervention in children of 5-10 years of age- A randomized placebo controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065045

Enrollment

Registered

2024-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: N399- Disorder of urinary system, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
PART 1- 1. Phytoconstituent analysis of the Amrabeeja tablet. 2. To search the docking and dynamics based predictive correlation of selected phytoconstituents of Amrabeeja with known targets of antidiuretic (Desmopressin). PART 2- Comparative analysis of Amrabeeja and Desmopressin on V2 receptor activity in Nocturnal Enuresis using cell line study. PART 3- Reduction in Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) in children with Shayyamutra (Nocturnal Enuresis) in 2 months.Timepoint: Baseline After 2 months of intervention After 2 months of follow up	—

Measure

Time frame

PART 1- 1. Phytoconstituent analysis of the Amrabeeja tablet. 2. To search the docking and dynamics based predictive correlation of selected phytoconstituents of Amrabeeja with known targets of antidiuretic (Desmopressin). PART 2- Comparative analysis of Amrabeeja and Desmopressin on V2 receptor activity in Nocturnal Enuresis using cell line study. PART 3- Reduction in Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) in children with Shayyamutra (Nocturnal Enuresis) in 2 months.Timepoint: Baseline After 2 months of intervention After 2 months of follow up

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Prerna Sharma

All India Institute of Ayurveda

prashantgupta27@gmail.com9990988860

Outcome results