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CTRI Number  CTRI/2024/06/068941 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Interventional]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative clinical study to evaluate the efficacy of two different ayurveda medicated enema therapies in paralysis Pakshaghata with special reference to ischemic stroke 
Scientific Title of Study   A randomized comparative clinical study to evaluate the efficacy of Mashaadi Kashaya Basti over Dashamoola Ksheera Basti in Pakshaghata with special reference to Ischemic Stroke 
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 Shreedevi B Huded 
Designation  PG Scholar 
Affiliation  D G M Ayurvedic Medical College Gadag Gadag 
Address  Department of Panchakarma Room number 2 Shri DGM Ayurvedic Medical College hospital and PG & PhD Studies center Kalasapura road Gadag

Gadag
KARNATAKA
582103
India 
Phone  6362581421  
Fax    
Email  shreedevi45huded@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jairaj P Basarigidad 
Designation  Professor HOD Panchakarma 
Affiliation  D G M Ayurvedic Medical College Gadag Gadag 
Address  Department of Panchakarma Room number 2 Shri D G M Ayurvedic Medical College hospital and PG & PhD Studies center Kalasapura road Gadag

Gadag
KARNATAKA
582103
India 
Phone  9448516176  
Fax    
Email  jairajpb111@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreedevi B Huded 
Designation  PG Scholar 
Affiliation  D G M Ayurvedic Medical College Gadag 
Address  Department of Panchakarma Room number 2 Shri D G M Ayurvedic Medical College hospital and PG & PhD Studies center Kalasapura road Gadag

Gadag
KARNATAKA
582103
India 
Phone  6362581421  
Fax    
Email  shreedevi45huded@gmail.com  
 
Source of Monetary or Material Support  
D G M Ayurvedic Medical college and Hospital pg and Phd studies and research center kalasapura road Gadag 582103 Karnataka India 
 
Primary Sponsor  
Name  Dr Shreedevi B Huded 
Address  Department of Panchakarma Room number 2 Shri D G M Ayurvedic Medical College hospital and PG and PhD Studies center Kalasapura road Gadag 
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 Shreedevi B Huded  Shri D G M Ayurvedic Medical College  Department of Panchakarma Room number 2 Shri D G M Ayurvedic Medical College hospital and PG & PhD Studies Kalasapura road Gadag 582103 Karnataka India
Gadag
KARNATAKA 
6362581421

shreedevi45huded@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
J S V V Samsthes DGM Ayurvedic Medical College Hospital PG studies and Research Center, Gadag  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: ashtanga hridaya sutrasthana 2nd chapter, Procedure details: 1. oil is taken and heated indirectly, applied on abdomen and flanks )
(1) Medicine Name: murchita tila taila, Reference: bhaishajya ratnavali chikitsasthana, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 8 Days
2Comparator ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: charaka sutrasthana , Procedure details: sudation is given to abdomen and flanks)
(1) Medicine Name: dashamula kwatha, Reference: charaka sutrasthana, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(g), Frequency: od, Duration: 8 Days
3Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charaka siddhisthana, Procedure details: Position of the subject: The subject is asked to lie down comfortably on his left side and to keep his head on his arm in the form of pillow while keeping the body straight and relaxed. Then the subject is asked to flex his/her right leg over his/her fully extended left leg. PRADHAMA KARMA:  Introduced the Basti Netra slowly in the direction of the vertebral column up to 1/4th part of the Netra.  Then hold the Basti Putaka in the left hand and keep the right hand on the Basti Netra.After that administer the Basti Dravya uniformly, neither too fast nor too slow without shaking the hand and instructed the patient to breath in deeply. )
(1) Medicine Name: dashamula ksheera basti, Reference: sushruta uttaratantra, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 480(ml), Frequency: od, Duration: 3 Days
4Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charaka siddhisthana, Procedure details: Position of the subject: The subject is asked to lie down comfortably on his left side and to keep his head on his arm in the form of pillow while keeping the body straight and relaxed. Then the subject is asked to flex his/her right leg over his/her fully extended left leg. PRADHAMA KARMA:  Introduced the Basti Netra slowly in the direction of the vertebral column up to 1/4th part of the Netra.  Then hold the Basti Putaka in the left hand and keep the right hand on the Basti Netra.After that administer the Basti Dravya uniformly, neither too fast nor too slow without shaking the hand and instructed the patient to breath in deeply. )
(1) Medicine Name: mashadi kashaya basti, Reference: yogaratnakara poorvardha , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with following signs and symptoms Chesta Nivrutti in Dakshina and Vama Parshwa Ardhakayakarmahani Vaksanga Ruja Suptata in hasta and pada Subjects suffering from Ischemic Stroke without any severe complications Subjects of either gender are included Subjects of age groups between 30-70 years are included Subjects fit for Basti Karma
 
 
ExclusionCriteria 
Details  Subjects having dysphagia Incontinence of bowel and bladder Subjects who are disoriented and unconscious Uncontrolled Diabetes Mellitus Hypertension Intracranial infections like meningitisen cephalitis etc Post traumatic stroke
Haemorrhagic stroke Space occupying lesions of brain such as tumours Congenital defects such as diffuse sclerosis cerebral agenesis etc & other major illness Subjects who are suffering with Chronic KidneyDiseases Acute Kidney Diseases Congestive Cardiac Failure& Ischemic Heart Disease
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in cardinal feature of Pakshaghata Chesta Nivrutti in Dakshina and Vama Parshwa Ardhakayakarmahani Vaksang Ruja Suptata in hasta and pada
 
after 24 days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of improvement through stroke scale of national health institute of neurological disorders & stroke NIH & NINDS & modified Rankins Disability Scale  after 24 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   28/06/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Vata is the only Dosha which governs all the other entities of the body like Pitta, Kapha, Dhatu etc. Diseases caused by Vata in its vitiated condition are called Vatavyadhi.Soa proper understanding of the concept of Vata is required in order to keep all the body functions in equilibrium.Although Vata is said to be dominated during the old age only,but in present timedue to fast and busy life,stress,prolonged sitting posture in working place dietaryhabits, working late night, improper sleep etc. Vata is seen to be aggravated even in the young individuals.

Pakshaghata is the major disabling disease manifests as a Paralysisof one side of the body due to the vitiation of Vata Dosha.Pakshaghata is Vata Vikaraof rapidly or gradual developing clinical science of focal or global disturbance of limbs movements and sensation and symmetrical loss of body functions. It manifests due to disturbance in the Vata Vaha Samsthana that is Mantishka, leading to impairment of function of Vata that is Chesthhani either in left or right of the body. Pakshaghata is one among the 80 Vata Vikarasa and being one among the Mahaghadas.

According to WHO, Stroke is focal and global disturbance of cerebral blood circulation which is either ischemic or Haemorrhagic with symptoms lasting 24 hours or longer are leading death. Stroke is leading cause of disability worldwide and 3rd leading cause of death and it not only changesphysical, mental, economical status of patient,but also of their family. The estimated prevalence rate stroke range 48-262/100000 in rural and 334-424/100000 Urban,incidence rate 119-145/100000 based on recent population. About 87% of all 1st ever in life time stroke are ischemic, 13% due to primary intra cerebral haemorrhage.

General approach of Stroke management including physiotherapy is part of rehabilitation following Stroke, it can help to restore the loss of movement and strength. But it has more limitation and restriction when compared to Ayurveda. In the management of Pakshaghatait is very difficult to make complete cure hence many patients retain permanent disability,spasticity and rigidity as a permanent damage. Toovercome such condition an attempt is made to evaluate the efficacy of Basti Karma.

The Basti is the treatment which is considered as best therapy to control Vata and to prevent Vimargamanaof Vata. Basti will dose the SarvadoshaShamana, Vatanulomanaand Srothoshodhana.Acharya Charaka highlighted that “BASTI VATA HARANAM SHRESTA”and it dose the Shodhanaof Dosha from “Pada to Mastishkya”, hence conclusively Basti is the Ardha Chikista.

In the present study DashamoolaKsheera Bastiis planned. Dashamoola possesses Vata and Kaphahara properties, it is included in ShothaharaMahakashaya by Acharya Charaka.Dashamoola having Madhura rasa, Laghu Guna and Madhura Vipaka helps to pacify vitiated Vata, Kashaya Rasa and Ushna Veerya does Amapachana & cleanses the Srotasa. Collectively the actions of Dashamoola are Vatahara, Parshvashulahara, Shothahar, Balya, Amapachaka.

Ksheer is having Madhura Rasa, Snigdha Guna, Madhura Vipaka and it is Jeevaniya, Balya, Anulomaka in nature.

DashamoolaKsheera Basti is widely practiced. Its compostionof the drug influences Vatanulomaka, Balya, Shothahara, Shoolahara, Amapachaka.

In the present study MashadiKashaya ingredients are Masha Beeja,Aatmagupta Beeja, Erandamoola, Balamoola, Saindhava Lavana andHinguhave the properties like Vatagna, Vedanastapana,Santarpana,Poustika,Balya,Bhrumhana,Shoolagna,Shothagna, Angamardaprashamana,Snehana,Tridoshashamaka,Vatashleshmahara,Vatanulomaka which is expected to manage the Pakshaghata effectively.

 
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