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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther 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
2Intervention ArmDrugOther 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. 
 
Method of Generating Random Sequence    
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.
 
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