An Open labelled Non Randomised Parallel group clinical controlled trial on Saraswata Ghrita ( oral) and Chaturbhadra Kalpa Basti in the management of Global developmental delay (GDD) in Children
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- State Ayurvedic college and hospital lucknow
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1. Improvement in quality of life in children .
Overview
Brief Summary
Global Developmental delay ( GDD ) is one of the most steadily rising complex neuromuscular developmental disorder in past few decades, but there is no certain treatment available in any modalities. Ayurveda is the ray of hope for such kind of clinical conditions.Therefore, I select this trial. Clinical trial will be done on two group A and B . In group A Saraswata ghrita using route of administration as Paan (Oral route) for 84 day’s without any gap and In Group B Chaturbhadra Kalp Basti (Per rectal route) ,12 day schedule ( 4 sneha vasti in beginning, 4 niruh vasti in mid, 4 sneha vasti in last ). Minimum 30 GDD diagnosed children, aged 1 to 5 years clinically studies of treatment modules. Each segment of treatment module will be for 84 day’s. After, each treatment there is a gap of 24 days in group B, Total duration of trial is 84 days. A follow up will be done after 30 days of complete clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Year(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Child between age Group of 1-5 yr of either sex are diagnosed GDD 2 .Child / parents willing to participate in the Trial.
- •Children with developmentaldisabilities of both physical and mental ( delayed milestone)
- •Unable to stand , walk, speech, sitting as per age.
- •Child with altered IQ as per age.
Exclusion Criteria
- •1.Child of age less then 1 year.
- •and more then 5 years.
- •2.Child with sever infection, systemic illness like TB.
- •Gastrointestinal disease 3.Child with genetic disorder like down syndrome or any congenital anomalies 4.Child suffering from any muscular dystrophy (DMD) 5.Child having abnormal CT/MRI brain finding with abnormal EEG finding.
Outcomes
Primary Outcomes
1. Improvement in quality of life in children .
Time Frame: After 84th day of trial
2. Improvement in speech/language/Communication/sociability/sensory/cognitive awareness , locomotary disability.
Time Frame: After 84th day of trial
Secondary Outcomes
- •To Check the efficacy of Saraswata ghrita in the case of GDD.(•To evaluate the role of Chaturbhadra kalp basti in GDD.)
Investigators
Dr Mamta Chandra
State Ayurvedic college and hospital lucknow