FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/059066 [Registered on: 23/10/2023] Trial Registered Prospectively
Last Modified On: 13/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to study the efficacy of Panchvalkala Kwatha in Shayyamutrata (Enuresis) in children of age 6 to 12 years. 
Scientific Title of Study   A Randomized, Open Labelled,Controlled,Clinical trial to study the efficacy of Panchvalkala Kwatha in Shayyamutrata(Enuresis) in children of age group 6 to 12 years. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rutuja Rahul Kate 
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital,Nanded 
Address  Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.

Nanded
MAHARASHTRA
431601
India 
Phone  9673285585  
Fax    
Email  rutujakate85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAshwini A Patil 
Designation  Assistant Professor 
Affiliation  Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded. 
Address  Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.

Nanded
MAHARASHTRA
431601
India 
Phone  9420247156  
Fax    
Email  organotech99@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAshwini A Patil 
Designation  Assistant Professor 
Affiliation  Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded. 
Address  Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.

Nanded
MAHARASHTRA
431601
India 
Phone  9420247156  
Fax    
Email  organotech99@gmail.com  
 
Source of Monetary or Material Support  
Goverment Ayurved College and Hospital Nanded Vazirabad Square Nanded 
 
Primary Sponsor  
Name  Dr Rutuja Rahul Kate 
Address  Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRutuja Rahul Kate  Government Ayurved College and Hospital,Nanded  Room no.2,Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.
Nanded
MAHARASHTRA 		 9673285585

rutujakate85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: SAYYAMUTRATVAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchvalkala Kwatha, Reference: Charaka Sutrasthan, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Tab Mentat, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  • Children complaining of Shayyamutrata i.e. enuresis between 6 to 12 years age group will be selected
• Repeated voiding of urine in the bed or clothes,2 or more than 2 times in a week, for at least 3 months.

 
 
ExclusionCriteria 
Details 
• Patients having systemic disorders like Diabetes Mellitus and Diabetes Insipidus.
• Patients with congenital anomalies or with anatomical defect in genital urinary system and UTI.
• Neurodevelopment disorders like Mental Retardation, Cerebral Palsy, Spina bifida and seizure disorders.
• Any systemic severe illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
No bedwetting or decreased frequency of bedwetting at the end of 60 days  0 Day
16th day
31st day
60th day 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effects of the Panchvalkala Kwatha.  60 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is Randomized,Open Labelled,Controlled Clinical trial to study the efficacy of Panchvalkala Kwatha in Shayyamutrata(Enuresis) in children of age group 6 to 12 years given as per the age twice a day after meals for 30 days and follow up on 16th,31th,60thday.This study is conducted as PG course at a single centre.The primary outcome is to study the effect of Panchvalkala Kwatha on Shayyamutrata. 
Close