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CTRI Number  CTRI/2024/03/063468 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study effect of Agnikarma in children with spastic cerebral palsy 
Scientific Title of Study   Evaluation of Agnikarma in management of spasticity in children with spastic cerebral palsy - a randomised controlled clinical trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR JEERU OJASWINI REDDY  
Designation  PG SCHOLAR 
Affiliation  KLE Shri B.M. Kanakanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka 
Address  Department of Kaumarabhritya KLE Shri B.M.Kankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  7978644281  
Fax    
Email  pooja.ojaswinireddy04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR UMA SHETTI 
Designation  READER 
Affiliation  KLE Shri B.M.Kanakanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka 
Address  Department of Kaumarabhritya KLE Shri B.M.Kankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9738467051  
Fax    
Email  dr.umashetti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR UMA SHETTI 
Designation  READER 
Affiliation  KLE Shri B.M.Kanakanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka 
Address  Department of Kaumarabhritya KLE Shri B.M.Kankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka


KARNATAKA
590003
India 
Phone  9738467051  
Fax    
Email  dr.umashetti@gmail.com  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital 
 
Primary Sponsor  
Name  KLE Ayurveda Hospital 
Address  KLE Shri B.M.Kankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR JEERU OJASWINI REDDY   KLE SHRI B.M.KANKANWADI AYURVEDA MAHAVIDYALAYA, BELGAVI KARNATAKA  ROOM NUMBER NO 10 AND 11 DEPARTMENT OF KAUMARABHRITYA
Belgaum
KARNATAKA 
7978644281

pooja.ojaswinireddy04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: SNAYUGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: sushruta samhita, Procedure details: Materials required for smooth conduction of abhyanga followed by nadi swedana has to be collected, they include oil, vessel, water, gas stove and pressure cooker, nadi yantra attached over its nozzel cotton. The child is allowed to stay in comfortable position. Smear oil and massage the luke warm oil over head, ear, neck, face, upper extrimities, trunk, lower extremities for a duration of 35 to 40 mins with 7 distinct position. Steam is applied to affected part using nadi yantra in sitting p)
(1) Medicine Name: sahacharadi taila, Reference: astanga hrudaya, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: caraka samhita, Procedure details: Materials required for smooth conduction of abhyanga followed by nadi swedana has to be collected, they include oil, vessel, water, gas stove and pressure cooker, nadi yantra attached over its nozzel cotton. The child is allowed to stay in comfortable position. Smear oil and massage the luke warm oil over head, ear, neck, face, upper extrimities, trunk, lower extremities for a duration of 35 to 40 mins with 7 distinct position. Steam is applied to affected part using nadi yantra in sitting p)
(1) Medicine Name: dasamoola kasaya, Reference: Bhaisajya ratnavalli, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: od, Duration: 7 Days
3Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: , Procedure details: Essential equipments such as sterile gloves, gauze piece, sterile draps, thermoregulated agnikarma instrument, madhu and ghrita was collected. Mark the affected part. Under aseptic condition painting and drapping was done of the affected part. Thermoregulated agnikarma instrument was heated through AC power to 200 degree celcius temperature by manually setting of temperature through keyboard. After reaching the temperature range, Agnikarma will be performed at site of spasticity in bindu )
4Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Susruta Samhita , Procedure details: The child is made to lie down in comfortable position. The appropriate site is selected and markings are done on the exposed area. The taila is heated until it starts to boil. The Taila is then taken in glass pipette. One drop of taila is made to fall on the marked spot in a sequence followed by immediate moping of the taila drops with aloe vera pulp. Child is allowed to rest and observed. )
(1) Medicine Name: Sahacharadi Taila, Reference: astanga hridaya, Route: Topical, Dosage Form: Taila, Dose: 1(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  • Children of either sex in age group between 5 years-16 years.
• Children fulfilling the diagnostic criteria.
• Children who have not received any form of modern intervention for spasticity at least for last 1 month.
 
 
ExclusionCriteria 
Details  • Children with non-spastic Cerebral Palsy will be excluded.
• Children with any known major congenital anomalies like Congenital Heart Disease (CHD) etc. will be excluded.
• Children with other disease status like Acute infections, severe systemic illness and children with any progressive neurologic anomalies will be excluded.
• Children with any other diseases or any other drugs that may interfere with the study outcome will be excluded.
• Children under gone any surgery intervention for spasticity will be excluded.
• Children having local inflammation or skin lesion on the site of spasticity will be excluded.
 
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ayurveda intervention by Agnikarma is known to reduce spasticity when measured on Modified Tardieu scale and
Composite spasticity index
 
0th day 7th day
 
 
 
Secondary Outcome  
Outcome  TimePoints 
Ayurveda intervention by Agnikarma is known to reduce spasticity when measured on Range of motion by Universal Goniometry
 
0th day 7th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cerebral palsy is a neuromotor disorder that affects the development of movement, muscle tone and posture. The motor disorders of Cerebral Palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior,as well as epilepsy and secondary musculoskeletal problems.. The prevalence of Cerebral Palsy is estimated to be between 2 to 3 cases per 1000 live births. Among the different types of Cerebral Palsy, Spastic Cerebral Palsy is the most frequent subtype, making up a significant proportion of approximately 70% to 80% of all cases. . The global incidence of Cerebral Palsy is 2:1000. In India the incidence of cerebral palsy is 3 per 1000 live birth.. The primary problems associated with spasticity are loss of balance, strength, and selective motor control of the muscles, and increased muscle tone which leads to problems such as fixed contractures and bony deformities that cause severe motor dysfunction in patients  .

In conventional medicine, treatments like Baclofen, Benzodiazepines, and Tizanidine, when administered over an extended period, can lead to side effects such as fatigue, hypotension, muscle rigidity, impaired mental status, hyper pyrexia, drowsiness, and potential Hepato toxicity.Tendon Lengthening Procedures are also used but this procedure is critical and on time the lengthened muscle gets weakened.

The Ayurveda diagnosis of this condition can also be linked to "Snayugata Vikara Vatavyadhi," where an imbalance of Vata and Kapha Doshas may result in symptoms such as Sthambha, Kampa, Sula, And Akshepa. There is a need today to find a protocol that works locally to help children with cerebral palsy to relieve spasticity. In Ayurveda different treatment modalities are mentioned for Vatavyadhi Chikitsa , Agnikarma  is one of the treatment may having role in  Vata vyadhi. Hence this study is taken for management of spasticity in children having cerebral palsy.

 
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