| CTRI Number |
CTRI/2024/04/066572 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of ayurvedic formulation in Bed wetting. |
|
Scientific Title of Study
|
A Single arm clinical Study to evaluate the efficacy of ayurvedic formulation in the management of shayyamutrata(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 |
Dr Mayuri Nemade |
| Designation |
MD Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
OPD N0.1 and IPD Kaumarbhritya Department, Dr.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar,Pimpri,Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8408860650 |
| Fax |
|
| Email |
mayurinemade99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Bhagwat |
| Designation |
Asso. Professor |
| Affiliation |
Dr. D.Y.Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD of Kaumarbhritya-Balrog Deparatment, Dr. D.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar, Pimpri,Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7588562700 |
| Fax |
|
| Email |
sbhagwat777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayuri Nemade |
| Designation |
MD Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center |
| Address |
OPD N0.1 and IPD Kaumarbhritya Department, Dr.Y.Patil College of Ayurved and Research Center, Sant Tukaram Nagar,Pimpri,Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8408860650 |
| Fax |
|
| Email |
mayurinemade99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D.Y.Patil College of Ayurved and Research Center,Sant Tukaram Nagar,Pimpri,Pune Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Mayuri Nemade |
| Address |
Dr D.Y.Patil College of Ayurved and Research Center,Sant Tukaram Nagar,Pimpri,Pune Maharashtra 411018 |
| 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 Mayuri Nemade |
Dr.D.Y.Patil College of Ayurved and Research Centre ,Pimpri Pune 18 |
OPD & IPD kaumarbhritya Department,Dr. D.Y.Patil College of Ayurved and Research Centre, Sant Tukaram Nagar,Pimpri,Pune Maharashtra 411018
Pune
MAHARASHTRA |
8408860650
mayurinemade99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: SAYYAMUTRATVAM, (2) ICD-10 Condition:F980||Enuresis not due to a substance orknown physiological condition. Ayurveda Condition: SAYYAMUTRATVAM, (3) 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 | Other than Classical | | (1) Medicine Name: Ayurvedic Formulation, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Ayurvedic formulation contains-
1.Jambu(Charak sutra 4/149-Mutrasangrahaneeya Gana)
2.Udumbar (Charak sutra 4/149-Mutrasangrahaneeya Gana)
3.Bimbimoola (Shlok No-167, Bhaishajya Ratnavali)
4.Ashwagandha (Shlok No-190, Bhavprakash Nighantu, Guduchyadi Varga)
5.Bramhi (Shlok No-280-281, Bhavprakash Nighantu, Guduchyadi Varga) |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
History of bed-wetting atleast twice in a week or more.
|
|
| ExclusionCriteria |
| Details |
Patients with any known case of -CNS disorders, Epilepsy, Spina bifida, Diabetes Mellitus, Diabetes Insipidus, Urinary tract infections, Any obstruction in Lower urinary tract like posterior urethral valve stenosis, distal urethral stenosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the frequency of bed wetting. |
30 days study with follow up on 15th and 30th day (0,15,30 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of Ayurvedic Formulation ,if any |
30 days study with follow up on 15th and 30th day (0,15,30 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)
|
10/05/2024 |
| 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 IS SINGLE ARM CLINICAL STUDY IN WHICH THE MEDICINE AYURVEDIC FORMULATION WILL BE PROVIDED TO 30 PATIENTS SHOWING SIGNS AND SYMPTOMS OF SHAYYAMUTRATA (ENURESIS). THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE BETWEEN 3 YEARS TO 15 YEARS. AYURVEDIC FORMULATION WILL BE GIVEN ON 0TH TO 30TH DAY AND THE TOTAL DURATION OF CASE STUDY WILL BE 30 DAYS.THE FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHODS. |