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CTRI Number  CTRI/2025/08/092233 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Ayurveda formulation on Infantile colic  
Scientific Title of Study   EVALUATION OF CHATURBEEJA ARKA IN MANAGEMENT OF UDARSHOOL WITH SPECIAL REFERENCE TO INFANTILE COLIC-A RANDOMIZED CONTROLLED CLINICAL TRIAL  
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 SUKANYA MAHADEV SWAMI 
Designation  PG SCHOLAR 
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarbhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590006
India 
Phone  7620422899  
Fax    
Email  sukanyaswami123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aziz Arbar 
Designation  HOD AND PROFESSOR  
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarbhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590006
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aziz Arbar 
Designation  HOD AND PROFESSOR  
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarbhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590006
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Source of Monetary or Material Support  
KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belgavi Karnataka 
 
Primary Sponsor  
Name  KLE Shri B M Kankanawadi Ayurveda Hospital 
Address  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belgavi Karnataka 
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 
Dr Sukanya Mahadev Swami  KLE Shri B M Kankanawadi Ayurveda Hospital  OPD no 10 Department of Kaumarbhritya KLE Shri B M K Ayurveda Mahavidyalaya Belgaum Karnataka
Belgaum
KARNATAKA 
7620422899

sukanyaswami123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for research on human subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital shahapur Belgavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: SULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chaturbeeja arka, Reference: Ravanakrta arka prakasha, Route: Oral, Dosage Form: Arka, Dose: 1(ml), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: Nil
2Comparator Arm (Non Ayurveda)-Simethicone20 mg qid for 3 days
 
Inclusion Criteria  
Age From  21.00 Day(s)
Age To  6.00 Month(s)
Gender  Both 
Details  AGE GROUP 3 WEEKS TO 6 MONTHS
INFANTS FULFILLING DIAGNOSTIC CRITERIA
 
 
ExclusionCriteria 
Details  Infants with an acute or chronic local or systemic infection will be excluded
Infants with known congenital gastrointestinal anomalies like intestinal obstructions hypertrophied pyloric stenosis etc
Children with known acute and chronic bowel disorders like vomiting diarrhea mal-absorptions etc
Infants with known Metabolic or Neurological disorder
Infants who are currently on other medications that may interfere with study outcome like anti spasmodics analgesics laxatives etc will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There might be significant effect of Chaturbeeja arka orally in the management of Udarshoola (Infantile colic) Measured by changes in FLACC Scale and VAS Scale

 
Minimum one day maximum 3 days 
 
Secondary Outcome  
Outcome  TimePoints 
There might be significant effect of Chaturbeeja arka orally in the management of Udarshoola (Infantile colic)Measured by changes in the Udarashool Parameters  Minimum one day maximum 3 days 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   01/01/2026 
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  
Infantile colic characterizes by persistent and inconsolable crying in infants more in the evening than at other times of the day .
Infantile colic is a common condition causing abdominal discomfort in newborns during the first few weeks after birth. The etiology of colic is still unknown, as the studies conducted so far have been restricted due to inadequate blinding and conflicting or inconsistent results. Many proposed contributing factors, such as biological, gastrointestinal, and psychosocial elements, define colic causes. 
Infant crying follows a developmental pattern, starting to increase around 2 weeks of age (corrected for gestational age at birth), peaking at 5 to 6 weeks, and declining by about 12 weeks. 
The prevalence of infantile colic between the age 0 to 6 months, ranges between 10 to 15 percentage.
The most common drug used for the treatment of infantile colic is simethicone which are more in line with the conclusion that this product is a safe placebo without significant therapeutic effects(4) and other common group of drugs like dicyclomine /dicycloverine which have adverse effects such as drowsiness, constipation, loose stools, and altered consciousness even when given at standard dosages.Hence there is growing need for more effective treatment modality for infantile colic.
The condition Infantile Colic can be correlated with Udarshoola as described in various Ayurvedic classics. In Ayurveda, various treatment modalities have been described by the Acharyas for the management of Udarashoola. One such formulation is Chaturbeeja Arka as mentioned in Ravanakrita Arka prakasha. This formulation possesses Shoolahara, Vatahara, Anulomaka , Deepana-Pachana properties. Due to its palatable nature, rapid onset of action, and efficacy in lower doses, chaturbeeja arka might be more effective in treating infantile colic.
 
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