CTRI/2025/06/089402Not yet recruitingPhase 2
Randomized controlled trial to evaluate the efficacy of Dheeradi Ghrita in the management of Attention Deficit Hyperactivity Disorder(ADHD) in children of age group 6 to 12 years
Anjali Pratap Thawrani1 site in 1 country60 target enrollmentStarted: September 7, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To study the effect of Dheeradi Ghrita in ADHD
Study Overview
Brief Summary
This study is a randomized open labelled controlled clinical trial comparing the safety and efficacy of Dheeradi ghrita 4ml thrice a day with koshna jala and controlled shankhpushpi and jatamansi siddha ghrita 4ml thrice a day with koshna jala for 45 days in 60 children of age group 6 to 12 yrs with Attention Deficit Hyperactivity Disorder (ADHD)
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group between 6 to 12 yrs.
- •Patient irrespective of their gender, religion and socioeconomic status.
- •Patients having Symptoms of ADHD for at least last 6 months.
- •Patients that fit in DSM IV criteria for diagnosis.
- •Children with no other neurological condition like mental retardation, down syndrome, microcephaly, etc.
Exclusion Criteria
- •Any serious neurological disease diagnosed earlier like cerebral palsy, mental retardation, microcephaly.
- •Any kind of systemic disease or chronic systemic disease like nephrotic syndrome, type 1 diabetes melitus.
- •disobedient parents.
Outcomes
Primary Outcomes
To study the effect of Dheeradi Ghrita in ADHD
Time Frame: 15 days
Secondary Outcomes
- To understand the disease ADHD in detail.(To find out ayurvedic correlation of disease with doshas and dushya.)
Investigators
Study Sites (1)
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