A non-randomised controlled trial to evaluate the combined effect of sirodhara with chandanadi ksheera and dhatryadi ghritha internally as compared to behavioral therapy in children with Attention-Deficit/ Hyperactivity Disorder in the age group 3-12 years
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To evaluate the combined effect of sirodhara with chandanadi ksheeram, datryadi ghritha internally and behavioral therapy and it is compared with behavioral therapy alone in inattention hyperactivity and impulsivity among children with ADHD in age group 3-12 years assessed by ADHD T2 and VADPRS
Study Overview
Brief Summary
Children in age group of 3-12 years, satisfying DSM 5 criteria for ADHD will be selected for the study from OPD of Government Ayurveda Hospital for women and child poojappura. The participants satisfying the DSM5 criteria for ADHD will be allocated into two groups, study group (15 participants) and control group (15 participants). The participants in the study group will receive proper preparatory measures like digestive correctives to make fit for internal snehapana and external sirodhara. The study group will receive datryadi ghritha 2.5 gm to 10 gm twice daily (empty stomach in morning and one hour before food in evening )for one month depending upon the age and weight of child, Sirodhara with chandanadi ksheera for 30 minutes for 21 days within a period of one month, modified behavioral therapy including the principles of CBT will be given for 5 days in a week for one month (study period one month). Control group will receive behavioral therapy including the principles of CBT 5 days in a week for one month. Both group participants will be assessed before, after and follow up period using ADHD T2 and VADPRS. Follow up peroid one month.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 3.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children who are fulfilling the DSM 5 criteria for ADHD within the age group of 3-12 years.
Exclusion Criteria
- •presence of any other psychiatric co-morbities history of recurrent lower respiratory tract infection children having intractable epilepsy.
Outcomes
Primary Outcomes
To evaluate the combined effect of sirodhara with chandanadi ksheeram, datryadi ghritha internally and behavioral therapy and it is compared with behavioral therapy alone in inattention hyperactivity and impulsivity among children with ADHD in age group 3-12 years assessed by ADHD T2 and VADPRS
Time Frame: 30days
Secondary Outcomes
- To evalute the overall changes in ADHD(30 days)
Investigators
Muhsina Javad
Government ayurveda college TVM
