| CTRI Number |
CTRI/2026/04/107696 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of Ashwatthadi Churna in the treatment of bed-wetting (nocturnal enuresis) in children. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Ashwatthadi Churna in the management of Shayyamutrata (nocturnal enuresis) in children. |
| 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 Shilpa Mohan Korekar |
| Designation |
MD Scholar, Kaumarbhritya |
| Affiliation |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Aurangabad |
| Address |
OPD no. 14, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan Road, Aurangabad, Maharastra
Aurangabad MAHARASHTRA 431011 India |
| Phone |
8446129248 |
| Fax |
|
| Email |
korekarshilpa9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kavita Fadnavis |
| Designation |
Professor |
| Affiliation |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Aurangabad |
| Address |
OPD no. 14, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan Road, Aurangabad, Maharastra
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kavita Fadnavis |
| Designation |
Professor |
| Affiliation |
Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Aurangabad |
| Address |
OPD no. 14, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan Road, Aurangabad, Maharastra
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,Paithan Road 431002 Aurangabad,
Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Dr Shilpa Mohan Korekar |
| Address |
OPD NO.14, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Paithan Road, Aurangabad, Maharastra |
| 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 Shilpa Mohan Korekar |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
OPD no 14,
Kaumarbhritya
department,CSMSS Ayurved
Mahavidyalaya and
Rugnalaya
Kanchanwadi, paithan road,
Aurangabad Aurangabad MAHARASHTRA |
8446129248
korekarshilpa9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee C.S.M.S.S. Ayurved Rugnalaya And Mahavidyalaya |
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 | Other than Classical | | (1) Medicine Name: Divyadi Yog, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -follow up - 15th, 30th, 60th, and 90th day | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwathhadi Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -follow up -
15th, 30th, 60th, and 90th day |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children complaining of Shayyamutrata i.e. Nocturnal enuresis between 5 to 12 years age group will be selected.
2. Repeated voiding of urine in the bed or clothes at night ,2 or more than 2 times in a week, for at least 3 months.
3. Patients irrespective of their sex, religion and socio-economiccal status.
4. Patients agreed for treatment and with informed consent. |
|
| ExclusionCriteria |
| Details |
1. Systemic disorders like Diabetes Mellitus and Diabetes Insipidus.
2. Congenital anomalies or with anatomical defect in genital urinary system and UTI.
3. Neurodevelopment disorders like Mental Retardation, Cerebral Palsy, Spina bifida and seizure disorders.
4. Any Other systemic illness.
5. Any Obstruction in Lower Urinary Tract Like Posterior urethral valve stenosis, distal urethral stenosis. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in frequency of nocturnal bed-wetting episodes in children with shayyamutrata. |
Baseline, day 15, day 30, day 60, and day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
17/04/2026 |
| 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)
|
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
|
In Shayyamutrata, the vitiated doshas primarily include Vata (Apana Vayu), Pitta (Pachaka pitta), and Kapha (Tarpaka kapha), along with the aggravation of the mental dosha, Tamas. And the Rasa dhatu (Ambu) is the affected dushya. The vitiation of Mutravaha and Manovaha srotas manifests as increased frequency of urine at night, which is untimely and disruptive to normal sleep patterns. This disruption indicates an imbalance in the Mutravaha and Manovaha strotas according to Ayurvedic principles. Hetu: A. Manasika Hetu= 1.Chinta 2.Bhaya 3.Krodha 4.Kautumbic Kalaha
B. Sharirika Hetu= 1.Krimi 2.Mutrashaya Shithilata 3.Niruddhaprakasha 4.Jananendriya Sankraman 5.Koshthabaddhata Considering pathology of the Shayyamutrata, treatment should be planned in a multidimensional approach. Counselling, Medhya drugs, Pramehaghna drugs, Dhatushaithilyahara drugs, krumighna drugs , kaphaahar drugs, vatanulomak drugs and Mutrasangrahniya drugs in combination may form a comprehensive protocol for management of Shayyamutrata.
The enuresis is defined as the voiding of urine in bed or in clothes (unintentional or deliberately ) as manifested by either a frequency of at least twice a week for at least 3 consecutive months or presence of clinically significant distress or impairment in social, academic (occupational), or other important areas of functioning when the child of about 5 years of age or more. The prevalence of Nocturnal Enuresis in Chhatrapati Sambhajinagar district among children of age 5 to 10 years was 10.91% in which 06.94% were males and 03.97% females. Withregard to severity 55% children were found to be in moderate category while 09% belonged to severe category of Nocturnal Enuresis.
In the modern medicine, management of Nocturnal Enuresis consist of behavioral modifications, bladder training, alarm therapy, diet management and use of drugs like desmopressin, anticholinergic agents, and tricyclic antidepressants like imipramine which having rare but serious adverse effect like cardiac arrhythmias. But none of the treatments till now can be completely relied upon. And relapse rates are high after stopping the medication.
It’s true that modern medicine hasn’t found a sure cure for Bedwetting, and some prescribed drugs may have side effects and limitations. While Ayurvedic treatments have shown promise in some studies, more research is needed for a conclusive understanding. Ultimately, a safe and effective cure for Bedwetting is still awaited, emphasizing the need for continued research and innovation in this area. |