| CTRI Number |
CTRI/2025/05/086640 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the efficacy of the Mutrasangarahaniya Yoga and Medhya Rasayan Yoga in the management Of Shayyamutra with special reference to Enuresis in children. |
|
Scientific Title of Study
|
A comparative clinic study on the efficacy of the Mutrasangarahaniya Yoga and Medhya Rasayan Yoga in the management Of 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 |
Rahul Kumar Singh |
| Designation |
PG Scholar (Ayu.) Dept. of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark- Buddha murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR
800003
India |
| Phone |
9113354760 |
| Fax |
|
| Email |
rufreerahul88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Chaurasia |
| Designation |
Professor and HOD, Department of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark- Buddha murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR
800003
India |
| Phone |
9835255180 |
| Fax |
|
| Email |
arvindschaurasia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Kumar Singh |
| Designation |
PG Scholar (Ayu.) Dept. of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark- Buddha murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR
800003
India |
| Phone |
9113354760 |
| Fax |
|
| Email |
rufreerahul88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Landmark- Buddha murti, Kadamkuan, Patna-800003, Bihar |
|
|
Primary Sponsor
|
| Name |
Rahul Kumar Singh |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark- Buddha murti, Kadamkuan, Patna-800003, Bihar |
| 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 Rahul Kumar Singh |
Government Ayurvedic College and Hospital, Patna |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark- Buddha murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR |
9113354760
rufreerahul88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC of Government Ayurvedic College and Hospital,Patna-800003,Bihar) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N394||Other specified urinary incontinence. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mutrasangarahaniya Yoga, Reference: Charaksamhita utraradh, chikitsasthanam , Medhya rasayana rasayanadhayay 3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -Group A - Medhya Rasayan
-Group B - Mutrasangrahniya Yoga |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
- Children having cardinal features of Shayyamutra without daytime incontinence.
- Children with repeated voiding of urine in bed or clothes at least 2-3 times in a week
|
|
| ExclusionCriteria |
| Details |
- Age below 5 years and above 12 years.
- Patients having systemic disorders like TB, DM, etc. were excluded from the study
- Patients with worm infestation or having any congenital anomalies or with anatomical defect of Genito-urinary system.
- Neurological disorders like Cerebral Palsy, MR, Spina bifida etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign and Symptoms will be assessed before and after treatment. i.e-Medha, Smriti, Dhriti, Vigyana, Priti, Sradha and Harsha etc |
- Group A 28 Days
- Group B 28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Blood: Routine and microscopic examinations. TC,DC,Hb,ESR and Urine: Routine and microscopic examinations investigations will be done in before and after.
|
- Group A 28 Days
- Group B 28 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/05/2025 |
| 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="0"
Months="8"
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
|
Paediatrics is concerned with the health of
infants, children and adolescents, their growth and development, and their
opportunity to achieve full potential as adults. The health problems of the
children in the third world are the most pressing. As physicians who assume a
responsibility for children’s physical, mental & emotional progress from
conception to maturity, paediatricians must be concerned with social &
environmental influences, which have a major impact on the health and well-being
of children and their families, as well as with particular organ systems and
biological processes. The young are often among the most vulnerable or
disadvantageous in society, and thus their needs require special attention.
Shayyamutra is one of the quite common obstinate problems which are behavioural/vegetative
disorder. Though no description regarding the Nidana, Samprapti etc is
available but Acharyas have described the specific treatments for the same that
shows their awareness on the disease since then. Also, this educates about the
starting of the disease to peep out at large in the society. So, this clinical study is open level efficacy and interventional clinical prospective study trial to assess the effect of mutrasanghrahaniya yoga& medyarasayana yoga in the management of shayyamutra(enuresis). This study will be conducted in Government Ayurvedic College and Hospital Patna Bihar. |