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A study to check the use of two ayurvedic medicines kalyanavaleha choornam orally and Panchabhoutika ghrita nasal drops in treating children with speech problem

Efficacy of kalyanavaleha choornam with panchabhoutika ghrita pratimarsha nasya in comparison to kalyanavaleha choornam alone in vaak vikara, primary developmental speech delay in children- an open labelled randomized controlled clinical trial. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080647
Enrollment
30
Registered
2025-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: F809- Developmental disorder of speech and language, unspecified

Interventions

None listed

Sponsors

Shri Dharmasthala Manjunatheshwara institute of ayurveda and hospital Bangalore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 . Children in the age range of 3-6 years identified with primary developmental speech delay irrespective of gender, religion and socio-economic status 2. Children diagnosed with primary developmental speech delay ranging from questionable delay to total delay in LEST 3. Children whose parents were willing to participate and sign the informed assent/ consent form 4. If participant history of epilepsy, well controlled by standard anti epileptic medication.

Exclusion criteria

Exclusion criteria: 1. Children with speech delay below 3 years and above 6 years of age 2. Children with congenital oral anomalies cleft lip, cleft palate requiring surgical intervention 3. Children with history of psychological, auditory and genetic disorder presenting with speech deformity 4. Children with history of poor controlled epilepsy, recurrent status epilepticus, intractable seizures, complex seizures, severe cognitive impairment

Design outcomes

Primary

MeasureTime frame
â?¢Improvements and difference in expressive and receptive language ability based on the pre-posttest assessment scores using REELS, â?¢Improvements and difference in Phonology, Semantics, Syntax-morphology, Pragmatics development chart using SLDC. Timepoint: 60 days

Secondary

MeasureTime frame
To compare the effect of oral administration of kalyanavaleha choornam with panchabhouthika ghrita pratimarsha nasya and kalyanavaleha choornam in control group on vaakvikara, primary developmental speech delay in children based on REELS, SLDC.Timepoint: 60 days

Countries

India

Contacts

Public ContactDr Thanmayee M A

Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda And Hospital,Anchepalya, Kumbalgodu post

srilakshmi.srinivas17@gmail.com8971263454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026