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CTRI Number  CTRI/2025/05/086930 [Registered on: 14/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of functional constipation in children 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Effect Of Shatahvadi Niruha Basti Over Pippalyadi Taila Matrabasti In The Management Of Vibandha(Funtional Constipation) 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 KALLAGODI LAKSHMIDEVI 
Designation  PG SCHOLAR 
Affiliation  Shree jagadguru gavisiddheswara ayurvedic medical college and Hospital, Koppal 
Address  OPD no 13, Dept of Kaumarabhritya, Shree jagadguru gavisiddheswara ayurvedic medical college post graduate studies and research center, Gavimat campus, Koppal
Gavimat campus,koppal
Koppal
KARNATAKA
583231
India 
Phone  9886594135  
Fax    
Email  klakshmidevi93981@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SURYANARAYANA MUDADLA 
Designation  Head of the Department 
Affiliation  Shree jagadguru gavisiddheswara ayurvedic medical college and Hospital, Koppal 
Address  OPD no 13, Dept of Kaumarabhritya, Shree jagadguru gavisiddheswara ayurvedic medical college post graduate studies and research center, Gavimat campus, Koppal
Gavimat campus,koppal
Koppal
KARNATAKA
583231
India 
Phone  7411642191  
Fax    
Email  surya83.m@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SURYANARAYANA MUDADLA 
Designation  Head of the Department 
Affiliation  Shree jagadguru gavisiddheswara ayurvedic medical college and Hospital, Koppal 
Address  OPD no 13, Dept of Kaumarabhritya, Shree jagadguru gavisiddheswara ayurvedic medical college post graduate studies and research center, Gavimat campus, Koppal
Gavimat campus,koppal
Koppal
KARNATAKA
583231
India 
Phone  7411642191  
Fax    
Email  surya83.m@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddheshwara Ayurvedic medical ollege and hospital, Koppal, Gavimat campus, Koppal(D), 583231 
 
Primary Sponsor  
Name  Dr Kallagodi Lakshmidevi 
Address  PG Scholar, Dept of Kaumarabhritya, SJGAMC Koppal 
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 Kallagodi Lakshmidevi  Shree Jagadguru Gavisiddheswara Ayurvedic medical college and Hospital, Koppal  OPD No 13, Dept of Kaumarbhritya
Koppal
KARNATAKA 
9886594135

klakshmidevi93981@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Kashyapa Samhitha, Procedure details: Position- left lateral position with flexing the right leg over fully extended left leg time of administration- Prathakala rikta koshta The anus and the enema nozzle are lubricated with oil after removing the air bubble, 1/4 of enema nozzle is introduced in the anus slowly and rightly following the curves of the spinal column without shaking or trembling. With a single act of compression on the receptacle, inject the content and then gradually withdraw the nozzle of the tube from the anus. )
(1) Medicine Name: Shatahvadi Kashaya and Shathaavadi Churna , Reference: Kashyapa Samhita Khila Sthana , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Kashyapa Samhitha, Procedure details: Position- left lateral position with flexing the right leg over fully extended left leg time of administration- Prathakala The anus and the enema nozzle are lubricated with oil after removing the air bubble, 1/4 of enema nozzle is introduced in the anus slowly and rightly following the curves of the spinal column without shaking or trembling. With a single act of compression on the receptacle, inject the content and then gradually withdraw the nozzle of the tube from the anus.)
(1) Medicine Name: Pippalyadi Taila , Reference: Ashtanga Hridaya Chikitsa Sthana , Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.The children of either gender between the age group of 1-10 years fulfilling the diagnostic criteria of Vibandha.
2. Children whose parents are willing to participate them in the study by giving informed parent consent 
 
ExclusionCriteria 
Details  Children with organic causes like Hirschsprung’s disease, inflammatory bowel disease, anatomical malformations of anal canal and hypothyroidism are excluded from the study.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Shatahvadi niruha basti has superior effect over Pippalyadi taila matrabasti in the management of Vibandha (functional constipation)  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Increased appetite  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 3 
Date of First Enrollment (India)   01/07/2025 
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="0"
Months="3"
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  
 Functional constipation is characterized by infrequent bowel movements, hard and/or large stools, painful defecation and fecal incontinence and is often accompanied by abdominal pain. It is one of the lifestyle disorders caused due to the suppression of urges and irregular eating habits. The prevalence of childhood constipation in general population varies widely ranging from 0.7% to 29.6% and a mean female to male ratio of 2.1:11. It accounts for 3% of visits to general paediatric clinics and accounts for up-to 25% of visits to paediatric gastroenterologist.  It is commonly seen among toddlers and pre-school children2 and it is more frequent when fibre dietary food and liquid diet intake are restricted. 
 
Though functional constipation is a gastro-intestinal disease, it also have the impact on the general health of a child, if not treated at the right time, it may lead to distress for the child further leading to recurrent discomfort in abdomen, reduced appetite, and the child even fears to defecate due to the pain experienced while passing hard stools. So, it is important that the disease is treated at the beginning stage itself before it leads to further complications like fissures, rectal prolapse and haemorrhoids. 
 
Main line of treatment according to modern science is considered to be use of laxatives like Polyethylene glycol, Lactulose, Magnesium Hydroxide etc and enemas like Bisacodyl, Sodium docustate which might temporarily relieve the condition and might reoccur later. 
 
Vibandha is one of the Vataja nanatmaja vikara mentioned in ayurveda which is analogous to Constipation.  It is caused due to Dusti of Apanavayu, Annavaha and Purishavaha srotas dusti. Apanavayu is one among the 5 types of Vata and the function of Apanavayu is Nishkramana of mala, mutra, shukra, arthava and garbha. Vibandha is frequently mentioned in ayurveda but no dedicated chapter is available for the same. It is mentioned as a Nidana, Poorvaroopa, Roopa, Upadrava and as a Panchakarma vyapad in various contexts in the classical texts and is seen as one of the symptoms in udavartha, anaha, adhmana, arsha.  
 
So far few researches have been done on constipation in children by administering internal medications like Haritaki, Trivruthadi avalehya, shuntyadi syrup etc. but there is a chance of getting acquainted to internal medications over the period of time. Hence, it is difficult to manage the condition alone with oral medications. 
 
For Vata vyadhi, Basti is one of the treatment mentioned in ayurveda and it is said as ardha chikitsa. But, basti is not been used frequently and not a single study on shodhana basti is available in existing data. Hence, Shodhana basti has been taken for present study. As alone Snehabasti can also relieve the condition but it may not do shodhana, hence Shodhana basti is selected here for the present study.  
 
Shatahvadi niruha basti mentioned in Kashyapa Samhita consist of Shatahva, Pippali, Kusta, Vacha, Devadaru, Poothika, Harenu, Bilva and Madanaphala and is said to relieve conditions like shoola, anaha and Vibandha. Hence present study has been taken to evaluate the effect of Shatahvadi niruha basti over Pippalyadi taila matrabasti in the management of Vibandha. 
 
 
 
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