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Clinical Trials/CTRI/2024/07/070527
CTRI/2024/07/070527Not yet recruitingPhase 2

A clinical study to evaluate the combined efficacy of Mahapaishachika ghrita orally and Balaswagandhalakshadi taila shiropichu in children with ADHD(Unmada)

Rakshitha C N1 site in 1 country30 target enrollmentStarted: August 1, 2024Last updated:

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

Sponsor
Rakshitha C N
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rakshitha C N

JSS Ayurveda Medical College And Hospital

Study Sites (1)

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