A trial to study the add on effects of Ayurveda in the treatment of cerebral palsy

Add on Efficacy and Functional outcomes of Combination of Ayurveda therapies along with oral administration of Ashwagandha churnam (a traditional Ayurvedic formulation made up of roots of Withania somnifera (L) Dunal ) in children with Spastic cerebral Palsy: A randomized controlled open label Pilot Study - AYUTONE

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021678

Enrollment

100

Registered

2019-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G80- Cerebral palsy

Interventions

Intervention1: 1. Ayurveda therapy (including Udwartana: 21 sessions, Abhyangam: 7 sessions, Kayaseka:14 sessions, Shiropichu: 21 sessions) along with Oral administration of Ashwagandha churnam 2.5- 1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children diagnosed with Spastic CP 2. Age between 2 and 12 years 3. Both Genders 3. Gross Motor Function Classification System levels II, III, IV&V (Detailed in Annexure- II) 4. Patients/guardian willing to comply with all study related visits and follow instructions as advised by consulting physician

Exclusion criteria

Exclusion criteria: 1. Children with Epilepsy 2. Children with fixed Contractures. 3. Children with systemic diseases such as renal or cardiac disorders 4. Any orthopaedic surgery 5. Subjects received botulinum toxin injection in the past 6 months, 6. Serial casting or new orthotics within the past 3 months. 7. Initiating or increasing oral medications that affect the neuromuscular system, e.g. baclofen, diazepam, within the past 3 months. 8. Children who are presently undergoing Modified Constraint Induced Movement Therapy(m-CIMT)

Design outcomes

Primary

Measure	Time frame
Spasticity by Modified Ashworth scaleTimepoint: Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study	—

Secondary

Measure	Time frame
1.Range of movement (ROM) by goniometry 2.Muscle strength using handheld dynamometer (wherever possible) 3.Gross motor function by GMFCS E&R 4.Cognition and Behaviour by Developmental Profile -3 and Child Behaviour Check List (CBCL) 5.Quality of Life by Ped. QOL inventory Timepoint: Baseline,1st month,2nd month, 3rdmonth and 2 months after completion of study	—

Countries

India

Contacts

Public ContactDr Gautam Sharma

All India Institute of Medical Sciences (AIIMS)

drsharmagautam@gmail.com011-26549326

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026