| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Simethicone | 20 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 |
|
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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. |