A clinical study to evaluate the combined efficacy of Mahapaishachika ghrita orally and Balaswagandhalakshadi taila shiropichu in children with ADHD(Unmada)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1 To evaluate the combined efficacy of Mahapaisachika Ghrita and Balaswagandhalaksadi
Study Overview
Brief Summary
Attention-deficit hyperactivity disorder (ADHD) is the neurobehavioral disorder characterized by inattention, including increased distractibility and difficulty sustaining attention, poor impulse control and decreased self-inhibitory capacity and motor over activity and motor restlessness. The Current treatment modalities available are behavioural therapies with or without psycho-stimulant drugs to control the symptoms.
In Ayurveda, ADHD can be correlated with “Unmada†based on similarity in clinical features or presentation. The clinical features explained in Kashyapa Samhita are Pralapa (Delerium), Vaichitya (Instability of mind) and Arati (Restlessness) which is applicable in children. Acharya Charaka explains Vibhrama of Manas, Budhi, Samjna, Jnana, Sheela, Cheshta and Achara in Unmada.
Mahapaishachika Ghrita polyherbal ghee based formulation mentioned in Charaka Chikitsa mainly indicated in all types of Unmada which improves Buddhi, Smrithi and Medha when used internally in age dependant divided dosage twice a day, before food with luke warm water for the duration of 28 days. Along with that a modality of Murdhini taila i.e. Shiropichu with Balashwagandalakshadi Taila pacifies Vata and also indicated in Unmada. External application of Shiropichu daily once Morning before bath,30 minutes/day for 14 days in 2 courses.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 3.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children in between the age group of 3-15 years irrespective of gender, religion and socioeconomic status.
- •Already diagnosed cases of ADHD (ICD-10-CM F90.0) 3) New cases of ADHD fulfilling the Diagnostic criteria as per DSM 5.
Exclusion Criteria
- •Know cases of Systemic and other Developmental disorders.
- •Know cases of any genetic disorders.
- •Diagnosed cases of psychological illness.
Outcomes
Primary Outcomes
1 To evaluate the combined efficacy of Mahapaisachika Ghrita and Balaswagandhalaksadi
Time Frame: Base line | 29th day
Taila Shiropichu on the clinical features of Unmada (ADHD) and on the scores of SWAN Rating scale of ADHD.
Time Frame: Base line | 29th day
Secondary Outcomes
- Reversal symptoms of Unmada (ADHD)(42th day)
Investigators
Dr Rakshitha C N
JSS Ayurveda Medical College And Hospital
