| CTRI Number |
CTRI/2021/03/031987 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Mahamasha Taila Matra Basti with Shashtika Shali Pinda Sweda and Ksheerabala Taila Orally in Cerebral Palsy |
|
Scientific Title of Study
|
A Clinical Study on Mahamasha Taila Matra Basti with Shashtika Shali Pinda Sweda and Ksheerabala Taila Orally in the Management of Cerebral Palsy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Astitva Tyagi |
| Designation |
M.D scholar |
| Affiliation |
State Ayurvedic Collage and Hospital, Turiyaganja, Lucknow |
| Address |
OPD no 2, Kaumarabhritya Deptt. State Ayurvedic Collage and Hospital, Turiyaganja, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9675482946 |
| Fax |
|
| Email |
astitvat25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Reader |
| Affiliation |
State Ayurvedic Collage and Hospital, Turiyaganja, Lucknow |
| Address |
OPD no 2, Kaumarabhritya Deptt. State Ayurvedic Collage and Hospital, Turiyaganja, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Reader |
| Affiliation |
State Ayurvedic Collage and Hospital, Turiyaganja, Lucknow |
| Address |
OPD no 2, Kaumarabhritya Deptt. State Ayurvedic Collage and Hospital, Turiyaganja, Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital, Lucknow |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
Tulsidas marg, Turiyaganj, Lucknow UP, 226004 |
| Type of Sponsor |
Government medical college |
|
|
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 Astitva Tyagi |
State Ayurvedic College and Hospital Lucknow |
Tulidas Marg Turiyaganj Lucknow UP
Lucknow
UTTAR PRADESH |
9675482946
astitvat25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ksheerabala taila orally |
Oral dose of Ksheerabala taila will be decided as per CCRAS 2005 guidelines.
For children of 1-5 age group: 5-15 drops per day
For children of 6-15 age group: 2-5 gms per day
Ksheerabala taila will be given for 90 days in group 1 only
Oral Ksheerabala taila will be given for 90 days of period without any gap in group B |
| Intervention |
Mahamasha Taila Matra Basti |
Basti is a type of Ayurvedic oil enema, medicine is administered through rectal route in this procedure. the dose of matra basti should be equal to harsva matra of sneha ( minimum dose of sneha)
Dose of Mahamash taila matra Basti will be decided on basis of classical reference as mentioned in Charak siddhi 4/53 and Kashyap samhita, minimum dose is one pala about 50 ml but according to bala kala desh agni tolerance capacity of the children the dose will be fixed for each patient, therefore according to per kg weight dose is approx. 1 ml/ kg body weight
Mahamasha tail matra basti will be given for 3 months of period. Matra basti will be administered for 15 days period after that 15 days of gap should be observed, Matra basti will be repeated after 15 days of period. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children physically and mentally handicapped due to cerebral palsy.
2.Children with delayed growth and milestone development.
3.Already diagnosed cases of CP
|
|
| ExclusionCriteria |
| Details |
1.Children below 1years and above 10 years of age.
2.Children of CP with major congenital disorder & other disease status viz. Juvenile DM, Acute infections etc.
3.Children with any progressive neurologic anomalies.
4.Child suffering from any Muscular dystrophy.
5.Children with severe systemic illness
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The research drug is expected to be beneficial for improving symptoms of cerebral palsy like muscle spasm, increase tendon extensibility, pain relief, inflammation, swelling and other symptoms of aggravated Vata Dosha, reduction in muscle spasticity and facilitate free movement of joint preventing from deformities and contractures. |
Three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Matra Basti shows good result in CP patients, especially by improving growth (height, weight, chest circumference) and development (head holding and sitting)
2.Ksheerabala oil is rejuvenating, which helps to repair the damaged tissue. It also provides nourishment to the nerves, brain, and spinal structures. The main ingredient of Ksheerabala Oil is Bala (Sida Cordifolia), which is a potent neuroprotective herb |
three months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this research we evaluate the efficacy of Mahamasha taila matra basti with Shashtik shali pinda sweda and Ksheerabala Taila orally in Cerebral palsy. This is a randomized parallel group trial Maximum 30 subjects will be taken aged between 1 to 10 years, in first group Mahamasha taila matra basti will be administered second group -Mahamash taila matra Basti and Ksheerbala Avartana taila orally will be administered in group Prior to Mahamash taila matra basti , Abhyanga with “Mahamasha Taila†and Shastik shali pinda sweda, will be done in each group. Dose of Mahamash taila matra Basti will be decided on basis of classical reference as mentioned in Charak siddhi 4/53 and Kashyap samhita, minimum dose is one pala about 50 ml but according to bala kala desh agni tolerance capacity of the children the dose will be fixed for each patient, therefore according to per kg weight dose is approx. 1 ml/ kg body weight
Dose of Ksheerabala taila will be decided as per CCRAS 2005 guidelines
For children of 1-5 age group: 5-15 drops per day
For children of 6-15 age group: 2-5 gms per day
DURATION OF TRIAL:-
It will be a trial of 90 days (approximate 3 month)
• 3 Schedules of Matra basti will be adopted i.e. 15 days Schedule.
• Matra basti of Mahamash Taila.
• One complete Schedule of Matra basti will be followed by gap of 15 days in both groups.
• Oral administration of Ksheerabala oil will be continued for 90 days without any gap only in group B.
FOLLOW UP – The clinical assessment of patients will be carried out during the trial, 1st on 15th day(after 1st schedule of matra basti) , 2nd on 30th day(after 15 days gap of 1st matra basti schedule), 3rd on 45th day(after 2nd Matra basti schedule) & 4th on 60th day(after 15 days gap of 2nd Matra basti schedule) .5th on 75th day(after 3rd Matra basti schedule). 6th on 90th day( after 15 days gap of 3rd Matra basti schedule)
• After the completion of trial, patients will be called for follow up after 1 month.
According to World Health Organization (WHO) estimation, 10% of the global population has some form of disability due to different causes; in India, it is 3.8% of the population.
For India, the estimated incidence is around 3/1000 live births; however, being a developing country, the expected actual figure may be much higher.
The few available treatments in modern medicine system to reduce generalized spasticity and another complications of cerebral palsy are associated with a high incidence of adverse effects and complications. There is an urgent need for studies to establish the efficacy of the Ayurvedic therapies and to find additional safe and effective treatments to help children affected by generalized spasticity due to CP. None of the oral medications used to treat spasticity in children has been adequately tested for safety and efficacy. There are minimal or no data regarding the pharmacokinetics or appropriate dosing parameters to treat children. These critical questions deserve serious research efforts. Currently there is no cure for CP. Answers can be found in Ayurvedic system of medicine. Ayurveda has been in use since time immemorial and is time tested. The present study was conducted with a goal to improve physical activity, capacity of mobility, social participation, and health-related quality of life in children with CP by means of Ayurvedic intervention using a combination of massage therapy, fomentation, and Ayurvedic drug administration through enema and oral route, i.e. Mahamasha taila matra basti and ksheerabala taila orally.
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