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Clinical Trials/CTRI/2024/08/071963
CTRI/2024/08/071963Not yet recruitingPhase 2

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

Muhsina Javad1 site in 1 country30 target enrollmentStarted: August 19, 2024Last updated:

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

Sponsor
Muhsina Javad
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Muhsina Javad

Government ayurveda college TVM

Study Sites (1)

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