A clinical trial to study the efficasy of an ayurvedic formulation in infantile colic
- Conditions
- Infantile colic
- Registration Number
- CTRI/2017/03/008237
- Lead Sponsor
- Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
- Brief Summary
This study is a open label, single arm clinical trial assessing the effectiveness of CaspaHerbal Carminative And Anti-Spasmodic Drops
Caspa Herbal CarminativeAnd Anti-Spasmodic Drops (i) 10drops (approx. 0.5 mL), 4 times a day, 15 minutes before feed, orally inInfants 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: for6 weeks in total 110 patients thatwill be conducted in one centre (SDM College of Ayurveda & Hospital,Hassan, Karnataka) in India. The primary outcome measures will be the signs andsymptoms of infantile abdominal colic at 6 weeks. The secondary outcome measureswill be patient’s quality of life and adverse drug reaction at 6 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 100
Infants with Infantile colic and whose parents willing to give consent to participate in the study.
Infants and young children suffering from acute illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Reduction in colic 6 weeks 2 Improvement in Appetite 6 weeks 3 Improvement in Digestion 6 weeks 4 Reduction in flatulance 6 weeks 5 Bowel activity 6 weeks 6 Improvement in General health 6 weeks 7 Weight gain 6 weeks
- Secondary Outcome Measures
Name Time Method Assessment of drug safety 6 weeks
Trial Locations
- Locations (1)
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
🇮🇳Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital🇮🇳Hassan, KARNATAKA, IndiaDr Shailaja UPrincipal investigator9448816433rao.shaila@gmail.com