CTRI/2025/06/089608 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On:
26/06/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Role of Mustadi Yapana Yoga Basti followed by Ashwattha Ksheerapaka and Bimbi Moola Ksheerapaka orally in Shayyamutra or Nocturnal Enuresis in children.
Scientific Title of Study
Randomised comparative clinical study to evaluate the efficacy of Mustadi Yapana Yoga Basti followed by Ashwattha Ksheerapaka and Bimbi Moola Ksheerapaka orally in Shayyamutra with special reference to 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 Bhaik Rahul Bajirao
Designation
PG Scholar
Affiliation
Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
Address
OPD No 9, Department of post graduate studies in Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
Bangalore KARNATAKA 560082 India
Phone
8308026011
Fax
Email
rahulbhaik123@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sudheer B R
Designation
Professor and HOD
Affiliation
Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
Address
OPD No 9, Department of post graduate studies in Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
Bangalore KARNATAKA 560082 India
Phone
9900175777
Fax
Email
sudheerbrao@yahoo.co.in
Details of Contact Person Public Query
Name
Dr Sudheer B R
Designation
Professor and HOD
Affiliation
Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
Address
OPD No 9, Department of post graduate studies in Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
Bangalore KARNATAKA 560082 India
Phone
9900175777
Fax
Email
sudheerbrao@yahoo.co.in
Source of Monetary or Material Support
OPD No 9, Department of post graduate studies in Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka, India. Pin-560082
Primary Sponsor
Name
Dr Bhaik Rahul Bajirao
Address
OPD No 9, Department of post graduate studies in Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082
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 Bhaik Rahul Bajirao
Sri Sri College of Ayurvedic Science and Research Hospital, Bengaluru.
OPD No 9, Department of post graduate studies in Kaumarabhritya, Sri Sri College of Ayurvedic Science and Research Hospital, 21st km , Kanakapura road , Udaypura post , Bengaluru. Karnataka -560082 Bangalore KARNATAKA
8308026011
rahulbhaik123@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:N399||Disorder of urinary system, unspecified. Ayurveda Condition: SAYYAMUTRATVAM,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Procedure
-
bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म
(Procedure Reference: charak samhita, Procedure details: Poorva Karma: Subjects will be asked to come for the treatment immediately after
taking food, Sthanika abhyanga to Abdomen, Buttocks & Thighs will be done &
Mridu Sweda with Ushna Jala will be done.
2. Pradhana Karma: Subjects will be asked to lie in the left lateral position by keeping
the left leg straight & the right leg flexed at knee joint. Under aseptic precautions, the
anus will be anointed by using a cotton swab dipped in oil & drug will be administered
using a rubber catheter attached to a Basti Yantra.
3. Paschat Karma: Gentle massage over the abdomen, back & plantar region will be
done after Basti administration.) (1) Medicine Name: Ashwagandha ghrita, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Duration: 5 Days
2
Intervention Arm
Procedure
-
bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म
(Procedure Reference: charak samhita, Procedure details: Poorva Karma: Subjects will be asked to come for the treatment in empty stomach.
Sthanika Abhyanga to abdomen, buttocks & thighs will be done. and Mridu Sweda with
Ushna Jala will be done.
2. Pradhana Karma: Subjects will be asked to lie in the left lateral position by keeping
their left leg straight and the right leg flexed at knee joint. Under aseptic precautions, the
anus will be anointed by using a cotton swab dipped in oil and drug will be administered
using a rubber catheter attached to the Niruha Basti Yantra.
3. Paschat Karma: Gentle massage over the abdomen, back and plantar region will be
done after Basti administration.) (1) Medicine Name: mustadi yapana basti, Reference: sushruta samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 3 Days
(Procedure Reference: charak samhita, Procedure details: Poorva Karma: Subjects will be asked to come for the treatment immediately after
taking food, Sthanika abhyanga to Abdomen, Buttocks & Thighs will be done and
Mridu Sweda with Ushna Jala will be done.
2. Pradhana Karma: Subjects will be asked to lie in the left lateral position by keeping
the left leg straight and the right leg flexed at knee joint. Under aseptic precautions, the
anus will be anointed by using a cotton swab dipped in oil and drug will be administered
using a rubber catheter attached to a Basti Yantra.
3. Paschat Karma: Gentle massage over the abdomen, back and plantar region will be
done after Basti administration.) (1) Medicine Name: Ashwagandha ghrita, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Duration: 5 Days
5
Comparator Arm
Procedure
-
bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म
(Procedure Reference: Charak samhita, Procedure details: Poorva Karma: Subjects will be asked to come for the treatment in empty stomach.
Sthanika Abhyanga to abdomen, buttocks & thighs will be done. and Mridu Sweda with
Ushna Jala will be done.
2. Pradhana Karma: Subjects will be asked to lie in the left lateral position by keeping
their left leg straight and the right leg flexed at knee joint. Under aseptic precautions, the
anus will be anointed by using a cotton swab dipped in oil and drug will be administered
using a rubber catheter attached to the Niruha Basti Yantra.
3. Paschat Karma: Gentle massage over the abdomen, back and plantar region will be
done after Basti administration.) (1) Medicine Name: Mustadi Yapana Kashaya basti, Reference: Sushruta samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 3 Days
1. Subjects diagnosed with Nocturnal enuresis between the age group of 6-12 years irrespective of their religion, gender and socio-economic status will be included.
2. Subjects with history of Nocturnal enuresis twice a week for at least 3 consecutive
months.
3. Subjects with both persistent and regressive type of Nocturnal enuresis
4. Subject whose parents are willing to sign written consent form and follow the protocol.
5. Subjects whose urine routine is normal.
ExclusionCriteria
Details
Subjects with Diurnal enuresis.
• Subjects who are known case of Spina Bifida, Vesico-Urethral reflux, Neurogenic
Bladder etc.
• Subjects who are known case of Neuro Muscular Developmental delay like Cerebral
palsy, Mental retardation, etc.
• Subjects who are known case of epilepsy and under anti-epileptic drugs.
• Subjects who are known case of Urinary Tract Infection and other renal Disorders.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Significant decrease in frequency and occurrence of Shayyamutra with special referance to Nocturnal enuresis assessed based on NICE Clinical guidelines.
0th, 8th, 30th, 60th day
Secondary Outcome
Outcome
TimePoints
•To understand the Nidana Panchaka of Shayyamutra with special reference to Nocturnal enuresis in children.
•To monitor the adverse drug reaction.
1 year
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 3
Date of First Enrollment (India)
10/07/2025
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="1"
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
Nocturnal Enuresis (NE), or bed-wetting, is a psychosomatic disorder that significantly affects the physical and emotional well-being of children, particularly beyond the age of five. It is prevalent in 10–15% of children aged 5–10 years and about 5% in those aged 10–15 years, with a higher incidence in boys. Children with Nocturnal Enuresis often suffer from low self-esteem, social withdrawal, and academic decline. Though often seen as behavioral,Nocturnal Enuresis is increasingly recognized as a developmental delay in achieving nighttime bladder control. While bladder overactivity is a primary cause, conventional treatments like bed alarms and Desmopressin have limitations in compliance and long-term efficacy. In Ayurveda, Nocturnal Enuresis corresponds to Shayyamutra, understood as Anyonya Avrita Vata and Tamo-Kapha Avarana of Hridaya, manifesting as Apana Avrita Vyana Vayu. Management includes Pakvashaya Shodhana with Yapana Basti and Grahi Chikitsa with Mootrasangrahaneeya Dravyas. Previous studies lack a holistic approach. This study aims to address Shayyamutra comprehensively through Mustadi Yapana Yoga Basti and oral administration of Ashwattha and Bimbi Moola Ksheerapaka, which offer Balya, Brimhana, and Mootrasangrahaneeya effects.