| CTRI Number |
CTRI/2025/09/094310 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to see the effect of Bimbimoola Syrup in Children who pass urine in Bed at Night |
|
Scientific Title of Study
|
Clinical evaluation of Bimbimoola Syrup in
Shayyamutra (Enuresis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nancy Singh |
| Designation |
PG Scholar |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department Of Kaumarbhritya Gurukul Campus Uttarakhand
Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8791400650 |
| Fax |
|
| Email |
singhnancy750@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepshikha |
| Designation |
Assistant Professor Department of Kaumarbhritya |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department Of Kaumarbhritya Gurukul Campus Uttarakhand
Ayurved University HaridwarUttarakhand
Hardwar
UTTARANCHAL
249404
India
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9013945535 |
| Fax |
|
| Email |
deepbhu10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GP Garg |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department Of Kaumarbhritya Gurukul Campus Uttarakhand
Ayurved University HaridwarUttarakhand
Hardwar
UTTARANCHAL
249404
India
Hardwar
UTTARANCHAL
249404
India |
| Phone |
6395611281 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttarakhand Ayurveda University Gurukul campus Haridwar Uttarakhand India Pin
code 249404 |
|
|
Primary Sponsor
|
| Name |
Nancy Singh |
| Address |
OPD No 9 Department of Kaumarbhritya Uttarakhand Ayurveda
University Gurukul campus Haridwar |
| 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 Nancy Singh |
Uttarakhand Ayurved University Gurukul campus Haridwar |
OPD 9 PG Department
Of Kaumarbhritya
Uttarakhand Ayurved
University Gurukul
campus Haridwar
Uttarakhand
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
8791400650
singhnancy750@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Gurukul Campus |
Approved |
| Institutional Ethical Committee Gurukul Campus UAU Haridwar |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bimbimoola syrup, Reference: Bhaishajya Ratnavali Kshudra Rogadhikara Adhyaya 66 Shlok number 167, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Sugar Syrup | This is Placebo Syrup |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children presenting with clinical feature of shayyamutra that is Repeated voiding of urine in bed or clothes twice a week for at least 3 consecutive months after 5 years of age.
2. Primary nocturnal enuresis.
|
|
| ExclusionCriteria |
| Details |
1.Children below 6 years and above 12 years.
2.Known case of Immune deficiency disorders, DM, DI and TB, Urinary tract infection, any other infection will be excluded, from the study.
3.Patients with any congenital anomalies or with anatomical deficits of genito-urinary system will not include in the study.
4.Secondary enuresis and diurnal eneuresis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bedwetting frequency
Lack of memory
Shamefulness
Irritability
Lack of Concentration
Fear
|
The assessment of patient will be done at 1st day, 15th day, and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in number of enuretic episodes per week ( Bedwetting frequency ) |
The assessment of patient will be done at 1st day , 15th day, & 30th day
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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
|
This study is a Single blinded Randomised clinical trial to determine the efficacy of Bimbimoola syrup in Shayyamutra (Enuresis) for the age group of 6 to 12 years for 30 days. Study will be conducted at UAU, Gurukul campus, Haridwar on 34 patients. Assessment will be done on the basis of subjective parameters. Study will be conducted at OPD/IPD level of PG department of Kaumarbhritya. The assignment will be done at interval of 30 days of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests |