CTRI Number |
CTRI/2021/12/038932 [Registered on: 27/12/2021] Trial Registered Prospectively |
Last Modified On: |
26/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Observational Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Observation of different Panchakarma treatments in Paralysis |
Scientific Title of Study
|
Evaluation of efficacy of panchakarma treatment protocol in pakshaghata (post stroke) –an observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NOT APPLICABLE |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sai Anuhya Velagapudi |
Designation |
PG Scholar |
Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
Address |
KAHERs SHri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
Phone |
7259495460 |
Fax |
|
Email |
anu.vsa13@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pradeep L Gramapurohit |
Designation |
Professor and HOD |
Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
Phone |
9964144197 |
Fax |
|
Email |
drpradeeplg.kaher@kleayurworld.edu.in |
|
Details of Contact Person Public Query
|
Name |
Dr Pradeep L Gramapurohit |
Designation |
Professor and HOD |
Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
Phone |
9964144197 |
Fax |
|
Email |
drpradeeplg.kaher@kleayurworld.edu.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
Address |
KAHERs SHri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
NOT APPLICABLE |
Not Applicable |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sai Anuhya Velagapudi |
KLE Ayurveda Hospital |
OPD no 04 and IPD Department of Panchakarma KLE Ayurveda Hospital and Research center Belagavi 590003 Belgaum KARNATAKA |
7259495460
anu.vsa13@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Cpmmittee for Research on Human Subjects |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | Not Applicable | (Procedure Reference: Not Applicable, Procedure details: Not Applicable)
| 2 | Comparator Arm | Procedure | - | Not Applicable | (Procedure Reference: Not Applicable, Procedure details: Not Applicable)
|
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients presenting with classical signs and symptoms.
Pakshaghata after acute stage
Either Gender
Patients aged between 30 – 70 years.
Fit for panchakarma.
Diagnosed case of Pakshaghata.
|
|
ExclusionCriteria |
Details |
Pakshaghata complicated with heart disease.
Pakshaghata secondary to neoplasms
H/O intra cranial infections – encephalitis, meningitis
Trauma
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Panchakarma treatments are efficacious in Pakshaghata |
Oth day and 7th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
NOT APPLICABLE |
NOT APPLICABLE |
|
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)
|
03/01/2022 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Globally, the incidence of noncommunicable
diseases is on the rise, drawing attention for its prevention and treatment.
Hemiplegia is one among them, causing physical and mental instabilities. Its
prevalence is about 9 cases/1000 in the global population. Worldwide,
cerebrovascular accidents (stroke) are the second leading cause of death and
the third leading cause of disability1. Hemiplegia is a
condition of total or partial paralysis of one side of the body, with numbness
in limbs, slurred speech, etc., Cerebrovascular accidents such as
thromboembolism and haemorrhage of cerebral arteries are the major cause for
this condition. This presentation is akin to a condition called Pakshaghata in
Ayurveda (Ch. Chi. 28/53). As it is explained by Acharya Madhava, “saadhyam
anyen samyukatamâ€2 means Pakshaghata along with other dosha is
easily curable.
The Commonest
cause of Hemiplegia is Cerebral Vascular Accident (CVD) or Stroke.
The worldwide
incidence has been quoted as 2 in 1000 population per annum, about 4 in 1000
population aged 45-84 years3.
The prevalence of stroke in India shows a huge
variation of 142-922/1,00,000 across the diverse community-based studies. 85%
of stroke cases are due to cerebral infarction, 15% are due to cerebral haemorrhage
and 1.5 times more often in male than in female4.
Taking all the
above points into consideration, its poor prognosis and nature of inertia, the
disease was selected, to find a measure that could help in restoring quality of
life in paralyzed patients. |