DaburPrimary · immunity
- Number of infection/allergy-related episodes
- Severity
- Duration of illness
Clinical Study 3 · Randomised · Open-label · Multicentre
Evaluation of Cyavanaprāśa in Healthy Children
CTRI/2015/02/005574, dated 24 February 2015
Title. Evaluation of Cyavanaprāśa on Health and Immunity Related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study.
Infection and allergy-related episodes
2.10×
more episodes in the control group than the CP group, P < 0.01
Population
5 to 12 years
Healthy school-going children at two school sites in Maharashtra
Randomised
702
DCP group 351, control/milk group 351
Completed
627
DCP 313, control 314
Duration
6 months
March 2015 to February 2016
Study flow
702
Randomised
CP 351Milk 351
627
Completed
CP 313Milk 314
6
Follow-up visits at Days 30, 60, 90, 120, 150 and 180
Design, participants and intervention
The study was a 6-month, two-arm, randomized, open-label, prospective, multicentre clinical study conducted between March 2015 and February 2016 at two school sites in Maharashtra, India. Ethics committee approvals were obtained before initiation and CONSORT reporting guidelines were followed.
Healthy school-going children aged 5–12 years were eligible. Children with significant medical/surgical conditions requiring long-term treatment, recent participation in another clinical study, significant uncontrolled disease or immuno-compromised status were excluded. Written parental/LAR consent and participant assent where applicable were obtained.
DCP group
About 6 g twice daily
Cyavanaprāśa, followed by a cup of milk.
Control group
Milk alone
Twice daily, approximately 100–200 mL.
Both groups continued their routine diet. Participants were followed for evaluation at Days 30, 60, 90, 120, 150 and 180. Compliance was assessed and adverse events were monitored at follow-up visits.
Outcomes
Secondary
- Number of children experiencing illness
- Number of absent days
- Number of children absent from school
- Quality of life using KIDSCREEN-27
- Energy
- Physical fitness
- Strength
- Stamina
- Physician’s global assessment using CGI-I
- Adverse events and serious adverse events
- Vital signs
- Overall safety and tolerability
Efficacy findings
CP versus controlInfection and allergy-related episodes
Total episodes 1,255. The control group recorded about 2.10 times more episodes than the CP group, P < 0.01.
Duration of illness, days
Total duration 3,983 days. Duration was about 1.91 times lower in the CP group, P < 0.01.
Children without immunity-related illness
2.22× higher
School-absence days
2.27× fewer
Absence due to infection or allergy
2.02× fewer
The differences in absenteeism were reported as statistically significant.
The source further reports improvements in energy, physical fitness, strength and stamina, with the CP group showing greater percentage improvement than the control group.
Quality of life
KIDSCREEN-27Quality of life was assessed using the KIDSCREEN-27 questionnaire. Improvements were reported in the domains of:
- Physical Activity and Health
- General Mood and Child’s Feelings
- School and Learning
The improvement in Physical Activity and Health was greater in the CP group, although the between-group difference was not significant for that domain.
Safety and tolerability
Physician safety assessment
Excellent 92.45%Good 5.87%Fair 1.68%Poor 0%
- Total AEs recorded
- 599
- AEs related to study drug
- 0
- Serious adverse events
- 14
- SAEs related to product or procedure
- 0
A total of 599 AEs were recorded, but none was considered related to the study drug; the study reported no adverse drug reaction. Fourteen serious adverse events were recorded, with none considered related to the study product or procedure.
Key takeaway
Cyavanaprāśa at about 6 g twice daily for six months significantly improved immunity-related outcomes in healthy children aged 5 to 12.
- Fewer infection or allergy episodes, lower illness duration, and less school absenteeism than milk control. Better quality of life in key domains.
- Favourable safety and tolerability with no adverse drug reaction. Well tolerated in healthy school children.