| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (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 | | 2 | Comparator Arm | Procedure | - | svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥ | (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 | | 3 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (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 | | 4 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (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 |
|
|
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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
|
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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 SHRESTAâ€and it dose the Shodhanaof Dosha from “Pada to Mastishkyaâ€, 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. |