| CTRI Number |
CTRI/2025/07/090389 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of vidang tandul yog vati with ashwagandhadi ghruta in shayyamutra,bedwetting,enuresis in children(5 to 12 years) |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the add - on effect of Vidang Tandul Yog Vati with Ashwagandhadi Ghruta in the management of nocturnal enuresis in children of age group 5-12 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 Bhakti Bharat Mane |
| Designation |
PG Student |
| Affiliation |
PDEAs college of Ayurved and Research centre nigadi |
| Address |
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
7387355613 |
| Fax |
|
| Email |
bmane8674@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sudha singh |
| Designation |
Guide |
| Affiliation |
PDEAs college of Ayurved and Research centre nigadi |
| Address |
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhakti Bharat Mane |
| Designation |
PG Student |
| Affiliation |
PDEAs college of Ayurved and Research centre nigadi |
| Address |
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
7387355613 |
| Fax |
|
| Email |
bmane8674@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya and Sterling multispeciality hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
|
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurved and Research centre nigadi |
| Address |
PDEAs college of Ayurved and Research centre balrog department third floor nigadi pune 411044 maharashtra India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhakti Bharat Mane |
Ayurveda Rugnalaya and sterling multi speciality hospital Nigadi |
PDEAs College of Ayurveda and Research Centre sector 25 nigadi pradhikaran Pune Ayurveda Rugnalaya and Sterling multispeciality hospital sector 27 nigadi pradhikaran pune 44 O/P/D No.118 PUNE MAHARASHTRA 411044 INDIA
Pune
MAHARASHTRA |
7387355613
bmane8674@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| chairperson institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F980||Enuresis not due to a substance orknown physiological condition. Ayurveda Condition: MUTRAJA-VRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vidang tandul yog vati , Reference: shushrut samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnjal), Additional Information: -(2) Medicine Name: ashwandhadi ghruta, Reference: raskamdhenu, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnjal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ashwagandhadi ghruta , Reference: raskamdhenu, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnjal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
patient of nocturnal enuresis will be selected from age group of 5-12 years of either gender
when urine is voided twice a week for at least three consecutive months DSM5 |
|
| ExclusionCriteria |
| Details |
patient with congenital anomalies
known case of diabetes mellitus diabetes insipidus metabolic disorder
known case of cystitis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study add on effect of vidang tandul yog vati with ashwagandhadi ghruta in the management of nocturnal enuresis in children of age group 5 to 12 years |
45 days with follow up 7th 15th 30th 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effect of drug if any |
45 days with follow up at 7th th 15th 30th 45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/08/2025 |
| 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="1"
Months="6"
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
|
Enuresis is a psychosomatic condition that frequently occurs in both girls and boys during their developmental periods. Boys suffer more often than girls. India estimate 7 to15 % prevalence rate among children and the numbers drop to 3to 5 % by the age of ten year. According to (DSM-5)- Enuresis is define, when urine is voided twice a week for at least three consecutive months or the bed wetting causes significant distress to the child.In ayurveda shayyamutra can be correlated with enuresis and there are very limited reference available. |