Effect of Dabur Lal Tail Massage on the Growth and Behavioral Assessment of Newborns and Babies.

A Placebo Controlled, Randomized, Prospective and Comparative Study to Assess the Efficacy and Safety of Dabur Lal Tail Massage on the Growth and Behavioral Assessment of Infants

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009238

Enrollment

Registered

2017-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dabur Lal Tail: Dabur Lal Tail is an Ayurvedic polyherbal baby massage oil, applied topically once a day for 10 weeks. Control Intervention1: Talcum Massage: Talcum powder, applied topi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Babies of either sex in the age group 7 days to 6 months, weighing 2500 grams or more (greater than or equal to 2500 g) at the time of birth 2. APGAR score > 7 at 1 and 5 minutes with no resuscitation required at birth 3. Exclusively breast-fed babies up to the age of 4 months and babies of age between 4 - 6 months who were top feed along with breast-feed 4. Medically stable babies without any requirement of drugs interventions/ procedures/ nutraceutical/ health supplement 5. Parents of the infant willing to sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Sick infants, infants with muscular trauma, skin infections, congenital anomalies or neuromuscular disorders 2. Known hypersensitivity to study product or any ingredient in the study product 3. Concomitant use medications known to adversely interact with the study drug or its related ingredients 4. Parents of the infants not willing to come for follow-up when required 5. Subjects participating in any other clinical trials

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Dabur Lal Tail massage on growth in neonates and infants in comparison with placebo massage and no massageTimepoint: 10 weeks (5 follow up visits)	—

Secondary

Measure	Time frame
To assess the safety profile of Dabur Lal TailTimepoint: 10 weeks (5 follow up visits)	—

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results