| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (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 | | 2 | Comparator Arm | Procedure | - | svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥ | (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 | | 3 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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 )
| | 4 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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.
 
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|
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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. |