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CTRI Number  CTRI/2025/08/092385 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Assess the ability of Avipattikar Churna (Avaleha) and Eranda Tila Taila Matra Basti in the management of Vibandha(constipation)in children 
Scientific Title of Study   A Randomized Clinical Trial to Evaluate the Comparative Efficacy of Avipattikar Churna (Avaleha) and Siddha Eranda Tila Taila Matra Basti in the the Management of Vibandha w.s.r. to Functional 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  Prof Minakshi 
Designation  Professor, Department of Kaumarbhritya 
Affiliation  RGGPG Ayurvedic College and Hospital 
Address  Room NO-218,Anatomy block,RGGPG Ayurvedic College and Hospital,paprola,Kangra,Himachal pradesh

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418017565  
Fax    
Email  drminakshi2050@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Minakshi 
Designation  Professor, Department of Kaumarbhritya 
Affiliation  RGGPG Ayurvedic College and Hospital 
Address  Room NO-218,Anatomy block,RGGPG Ayurvedic College and Hospital,paprola,Kangra,Himachal pradesh

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9418017565  
Fax    
Email  drminakshi2050@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar 
Designation  PG Scholar 
Affiliation  RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh 
Address  RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9459755903  
Fax    
Email  dr.pundir09@gmail.com  
 
Source of Monetary or Material Support  
Charaka Government Ayuervedic Pharmacy Paprola,Distt. Kangra Pin code 176115 Herbal Garden and Herbarium,Research Institute in ISM, Jogindernagar, Distt. Mandi Pin code 175015 
 
Primary Sponsor  
Name  RGGPG Ayurvedic College 
Address  RGGPG Ayurvedic College and Hospital,Paprola,Kangra 176115 
Type of Sponsor  Research institution and hospital 
 
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 
Prof Minakshi  RGGPG Ayurvedic Hospital, Paprola  OPD No. 217, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH 		 9418017565

drminakshi2050@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (HUMAN)  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
1Comparator ArmDrugClassical(1) Medicine Name: Avipattikara Churna(Avleha), Reference: Bhaishajaya ratnawali amplapittadhikara 24-27, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 70(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: Avipattikara Churna is used in Avleha form in the patients of Constipation
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Kashyapa Khila Sthan 8/104-109, Procedure details: Matrabasti is given with sidhha eranda taila & dose is decided according to age as per Kashyapa Khila sthana )
3Comparator ArmLifestyle--Dinacarya: Early to bed Early to rise Plenty of fluids Fibre rich diet Avoid Sedentary lifestyle, Ritucarya: Sesonal fruits and vegetables Taking meal according to Dosha Prakopa and Kaal Avoid excessive physical activities in Grishma and Varsha ritu to avoid Vata Prakopa, Acara Rasayana:Use of Milk and Ghrita daily, Other:-, Pathya/Apathya:yes, Pathya:Plenty of fluids Fibre rich diet Sesonal fruits and vegetables , Apathya:Junk food Spicy food Tea Coffee
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patient between 3-12 years of age.
2.Patient fufilling the Rome3 Criteria.
3.Parents of patient willing to participates in the trial. 
 
ExclusionCriteria 
Details  1.Children below 3 years and above 12 Years age.
2.Patient suffering from Constipation due to organic causes.
3.Chidren with physical disability and congenital anomaly.
4.Children with Chronic ailment like Tuberculosis,Malignancy,Renal problems,UTI,Diabetes mellitus,Hypothyroidism or any other chronic illness.
5.Parents of the patient not willing to participate in the trial.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fulfilment of Subjective and objective criteria  3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Control of Constipation in children  3 weeks 
 
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 
Date of First Enrollment (India)   15/08/2025 
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="0"
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   Out of 60 patients, 20 patients will be treated with Avipattikar Churna (Avleha) , 20 patients will be managed with Siddha Eranda Tila Taila Matrabasti and 20 patients will be managed with dietary and lifestyle modification to compare and evaluate their efficacy in Vibandha w.s.r. to Constipation in children. 
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