| CTRI Number |
CTRI/2026/01/101568 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study On Ayurvedic Shayyamutratanashak Churna And Bimbimool Vati For Treating Night Time Bedwetting In Children Age Group 5 to 10 Years. |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study To Evaluate The Efficacy Of Shayyamutratanashak Churna With Bimbimoola Vati In The Management Of Shayyamutrata (Nocturnal Enuresis) In Children Aged 5 to 10 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 |
Ashok Hansaram Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda college and research center sangamner |
| Address |
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9930384058 |
| Fax |
|
| Email |
ak162384@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Arjun Hase |
| Designation |
Professor |
| Affiliation |
Siddhakala Ayurveda College and Research Center Sangamner |
| Address |
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960688468 |
| Fax |
|
| Email |
drpramodhase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Hansaram Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda college and Research Center Sangamner |
| Address |
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9930384058 |
| Fax |
|
| Email |
ak162384@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya,Pimparane Road,Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra,India, Pincode-422605 |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Hansaram Choudhary |
| Address |
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Ashok Hansaram Choudhary |
Siddhakala Ayurveda Mahavidyalay And Hospital,Pimparne Road, Sangmaner |
OPD NO 4, Kaumarbhritya Department, Siddhakala Ayurved Mahavidyalaya, Pimparane Road, Sangamner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605
Ahmadnagar
MAHARASHTRA |
9930384058
ak162384@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board Of Research And Statistics Committee Of Siddhakala Ayurved Mahavidyalaya , Sangamner |
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: SAYYAMUTRATVAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: BIMBIMOOLA VATI, Reference: BHAISAJYA RATNAVALI CHAPTER KSHUDRA ROGADHIKAR SHLOKA NO 165 TO 167, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: NA | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SHYYAMUTRATANASHAK CHURNA, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: MADHU), Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children complaining about Shayyamutrata i.e. Nocturnal Enuresis between 5 to 10 years age group will be selected
2.Repeated voiding of urine in the bed or clothes,2 or more than 2 times in a week, for at least 3 months.
3.The patient whose parents are ready for their child’s participation. |
|
| ExclusionCriteria |
| Details |
1.Children presenting with diurnal enuresis
2.Patients with K/C/O Diabetes Mellitus and Diabetes Insipidus.
3.Patients with congenital anomalies or with anatomical defects in genital urinary system and UTI.
4.Neurodevelopment disorders like Mental Retardation, Cerebral Palsy, Spina bifida and seizure disorders.
5.Any systemic severe illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Efficacy of Shayyamutratanashak Churna with Bimbimoola Vati in reducing the frequency of bedwetting episodes in children aged 5 to 10 years diagnosed with Shayyamutrata (nocturnal enuresis), over a treatment period of 45 days |
15th Day (Baseline Assessment) , 45th Day (Final Assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the safety and tolerability of Shayyamutratanashak Churna and Bimbimoola Vati in children.
2.To assess the improvement in associated psychological symptoms such as irritability and sleep disturbances in children with Shayyamutrata (nocturnal enuresis) after administration of Shayyamutratanashak Churna and Bimbimoola Vati over a period of 45 days. |
0th Day , 15th Day (1st Follow up), 30th Day (2nd Follow up), 45th Day (3rd Follow up) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/02/2026 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Comparative Clinical Trial Comparing Safety And Efficacy of Shayyamutratanashak Churna 1.75gm to 2.75gm BD With Madhu And Comparing With Bimbimoola Vati 125mg to 250mg BD For 45 Days In 80 Patients Of Shayyamutrata Divided In Two Groups And Effect On Frequency of bedwetting , Irritability, Sleep Disturbance Will be Assessed Before And After Treatment. |