| CTRI Number |
CTRI/2024/05/067821 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Pakshaghata(Hemiplegia) through Virechana Karma And Matra Basti Karma |
|
Scientific Title of Study
|
A Clinico Comparative Study Between Virechana Karma And Matra Basti In The Management Of Pakshaghata W.S.R. To Hemiplegia An Open Labelled Randomized Comparative 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 Yagnitsinh Viharia |
| Designation |
Pg Scholar |
| Affiliation |
Government Akhandanand Ayurved College Ahmedabad Gujarat India 380001 |
| Address |
opd no 5, Government Akhandanand Ayurveda College And Hospital Bhadra Ahmedabad Gujarat India 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
6354588861 |
| Fax |
|
| Email |
yagnitviharia5798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupali Raut |
| Designation |
Associate Professor |
| Affiliation |
Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001 |
| Address |
opd no 5 Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
8849830133 |
| Fax |
|
| Email |
rautkajal77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krupali Raut |
| Designation |
Associate Professor |
| Affiliation |
Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001 |
| Address |
opd no 5 Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
8849830133 |
| Fax |
|
| Email |
rautkajal77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001 |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved College And Hospital |
| Address |
opd no 5 Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001 |
| 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 Yagnitsinh Viharia |
Government Akhandanand Ayurved College And Hospital |
opd no 5 Government Akhandanand Ayurved College And Hospital Bhadra Ahmedabad Gujarat India 380001
Ahmadabad
GUJARAT |
6354588861
yagnitviharia5798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT AKHANDANAND AYURVEDA COLLEGE INSTITUITIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATAH/PAKSHAVADHAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dIpana , दीपन | (Procedure Reference: charak samhita, Procedure details: Dipana and Pachana  Drug -Trikatu Churna with goghrita.
 Dose - 4 to 6 gm per day (2 to 3 gm twice a day per Aatura Agni).
 Time of Administration - Before Food.
 Anupana - Ushna Jala.
 Route – Oral Route 3 to 5 Days
(till the appearance of Nirama Lakshana achieved.)
)
| | 2 | Intervention Arm | Procedure | - | AByantarasnehaH, आà¤à¥à¤¯à¤¨à¥à¤¤à¤°à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: charak samhita, Procedure details: Snehapana  Drug - Shvadamstradi Taila.
 Dose - 20-40 ml starting dose, in vardhamana Krama (as per Aatura-Kostha and Agni).
 Time of Administration –Early Morning at empty stomach
 Anupana – Ushna Jala.
 Route – Oral Route
 Diet – Light Diet (drava, ushna, annabhishyandi,natisnidgha,asankirna) 3 to 7 Days
(Depending upon the Appearance of Samyak
Snigdha Lakshana).
)
| | 3 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: charak samhita, Procedure details: Abhyanga and Bashpa Sweda  Drug - Nirgundi Taila – Q.S. (Approx. 50 ml)
 For 1st , 2nd , 3rd day during vishrama kala after completion of abhyantar snehapana and also 4th day – prior to virechana karma. 4 days
)
| | 4 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® Pradhan Karma | (Procedure Reference: charak samhita, Procedure details: Pradhan Karma Virechana Karma  Drug - With Erand Taila [20-60 ml] And Godugdha (Cow’s Milk) [100 ml]
[ Mrudu Kostha – 20 ml
Madhyam Kostha – 40 ml
Krura Kostha – 60 ml ]
 Time of Administration - Sleshma kale gate-Anannam (After 10 am) Empty Stomach
1 day
)
| | 5 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak samhita, Procedure details: Pradhan Karma Matra Basti  Drug – Shvadamstradi Taila – 60 ml.
 Time of Administration - Immediately After LUNCH
 Route – Anal Route
 Position – Left Lateral 21 Days
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex with age between more than 18 to less then 60 years.
Patient having signs and symptoms of Pakshaghata fulfilling diagnostic criteria.
Patients who are Yogya for Virechana Karma and Basti Karma.
Mild to moderate hypertensive shall be considered.
Chronicity of disease limits upto 5 year. |
|
| ExclusionCriteria |
| Details |
Patient having age less then 18 and more than 60 years.
Patients who are Ayogya for Virechana Karma and Basti Karma.
Uncontrolled hypertension.
Patients of Intracranial infection on the basis of previously done Investigation.
Intracranial space occupying lesions and trauma on the basis of previously done Investigation.
Patients with altered sensorium.
Chronicity of disease limits more than 5 year. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve the disability produced by Pakshaghata. |
follow up will be done weekly for 1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve quality of life of patient |
follow up will be done weekly for 1 month. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/07/2024 |
| 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="1"
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
|
RESEARCH QUESTION:
Is Virechana karma as effective as Matra Basti in the management of Pakshaghata ?
HYPOTHESIS:
Null Hypothesis [ H0]: There is no
significant difference in the effect between Virechana Karma and Matra
Basti in the management of Pakshaghata.
Alternative
Hypothesis:
[ H1]: The effect of Virechana Karma is more
significant than the effect of Matra Basti in the management of Pakshaghata.
[
H2]: The effect of Matra Basti is more significant
than the effect of Virechana Karma
in the management of Pakshaghata.
AIM:
To evaluate and compare the effect of Virechana karma and Matra Basti in the management of Pakshaghata.
OBJECTIVES:
· To study the complete aetiopathology, symptomatology and
progress of Pakshaghata according to
Ayurveda as wells as modern science.
· To Study Virechana
karma as per ayurvedic texts.
· To Study Basti karma as per ayurvedic texts. To observe and analyse the effect of Virechana karma and Matra Basti in the management of Pakshaghata. DIAGNOSTIC CRITERIA:
Subjective criteria
v Vama
paksha
or dakshina paksha chesta nivrutti (Diminished
movements).
v Vak
stambh
(Impaired speech).
v Pada
sankocha
(contracture of lower limb).
v Hasta
sankocha
(contracture of upper limb).
v Gamane
kashtata (difficulty
in walking).
Objective criteria
· Examination
·
NIH STROKE SCALE
·
Neurological
Examination(Higher Mental Functions,Cranial Nerves,Motor Functions,Sensory
Function,Gait,etc) will be done before and after treatment.
· Investigations
Following
investigations will be carried out before and after treatment.
v Hematological examination – CBC WITH
ESR.
v Bio-chemical examination –Electrolyte,
RBS, Urine Routine & Microscopy
v Lipid profile (If Required)
|