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CTRI Number  CTRI/2017/03/008237 [Registered on: 27/03/2017] Trial Registered Retrospectively
Last Modified On: 13/03/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the efficasy of an ayurvedic formulation in infantile colic 
Scientific Title of Study   An Open Label, Single Arm Clinical Trial on Effectiveness and Safety of Caspa - A Herbal Carminative, Anti-spasmodic Drops in Infantile Abdominal Colic in Children between 2 to 24 months of age  
Trial Acronym  IAC-VACD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailaja U 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Dept Of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  9448816433  
Fax    
Email  rao.shaila@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailaja U 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Dept Of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  9448816433  
Fax    
Email  rao.shaila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijayalaxmi Mallannavar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Dept Of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  abtittu@gmail.com  
 
Source of Monetary or Material Support  
Vasu Research Centre [VRC] (A Division of Vasu Health Care Pvt. Ltd.), 896/A, G.I.D.C., Makarpura, Vadodara- 390010, Gujarat, India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Vasu Research Centre VRC  Vasu Research Centre [VRC], (A Division of Vasu Health Care Pvt. Ltd.), G.I.D.C., Makarpura, Vadodara- 390010, Gujarat, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailaja U  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Room No 02 Kaumarabhritya Out Patient Department
Hassan
KARNATAKA 		 9448816433

rao.shaila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Infantile colic,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caspa Herbal Carminative And Anti-Spasmodic Drops  Infants between 2 to 12 months: 10 drops (approx. 0.5 mL), 4 times a day, 15 minutes before feed, orally Young children between 13 months to 24 months: 20 drops (approx. 1 mL), 4 times a day, 15 minutes before feed, orally for 42 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  Infants with Infantile colic and whose parents willing to give consent to participate in the study 
 
ExclusionCriteria 
Details  Infants and young children suffering from acute illness  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1 Reduction in colic
2 Improvement in Appetite
3 Improvement in Digestion
4 Reduction in flatulance
5 Bowel activity
6 Improvement in General health
7 Weight gain


 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of drug safety  6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   16/05/2016 
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)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is a open label, single arm clinical trial assessing the effectiveness of Caspa Herbal Carminative And Anti-Spasmodic Drops

Caspa Herbal Carminative And Anti-Spasmodic Drops (i) 10 drops (approx. 0.5 mL), 4 times a day, 15 minutes before feed, orally in Infants between 2 to 12 months for 42 days  (ii) 20 drops (approx. 1 mL), 4 times a day, 15 minutes before feed, orally Young children between 13 months to 24 months: for 6 weeks in total 110 patients that will be conducted in one centre (SDM College of Ayurveda & Hospital, Hassan, Karnataka) in India. The primary outcome measures will be the signs and symptoms of infantile abdominal colic at 6 weeks. The secondary outcome measures will be patient’s quality of life and adverse drug reaction at 6 weeks.  
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