| CTRI Number |
CTRI/2023/10/058622 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic clinical trial on Paralysis |
|
Scientific Title of Study
|
Randomized Clinical Study On Mahavatavidhvansa Rasa–Vaitarana Basti-Shirobasti in Combination on Pakshavadh with special reference to Cerebral Infarction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Thatere |
| Designation |
Assistant professor |
| Affiliation |
Goverment Ayurved College and Hospital, Nagpur |
| Address |
2nd floor Department of Kayachikitsa Government Ayurveda College Raghuji Nagar Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9423406821 |
| Fax |
|
| Email |
ashish.thatere@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anaya Pathrikar |
| Designation |
Professor and Head of Department |
| Affiliation |
A.P.Ms Ayurvedic Mahavidyalaya sion mumbai |
| Address |
APMs Ayurved Mahavidyalaya Sion Ayurvedic Prasarak Mandal Road Sion Railway colony sion west sion mumbai
Nagpur
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Thatere |
| Designation |
Assistant professor |
| Affiliation |
Goverment Ayurved College and Hospital, Nagpur |
| Address |
2nd floor Department of Kayachikitsa Government Ayurveda College Raghuji Nagar Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9423406821 |
| Fax |
|
| Email |
ashish.thatere@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.P.Ms Ayurvedic Mahavidyalaya sion Mumbai
Government Ayurved College Nagpur |
|
|
Primary Sponsor
|
| Name |
Ashish Arunkumar Thatere |
| Address |
2nd floor Department of Kayachikitsa Government Ayurveda College Raghuji Nagar Nagpur 440024 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Arunkumar Thatere |
A.P.Ms Ayurveda Mahavidyalaya, Sion, Mumbai |
A.P.Ms Ayurveda Mahavidyalaya Ayurvedic Prasarak Mandal Road Sion Railway Colony Sion West mumbai- 400022
Nagpur
MAHARASHTRA |
9423406821
ashish.thatere@gmail.com |
| Dr Ashish Arunkumar Thatere |
Government Ayurveda College And Hospital, Nagpur |
2nd floor, Department of Kayachikitsa, Government Ayurveda College, Raghuji nagar- 440024
Nagpur
MAHARASHTRA |
9423406821
ashish.thatere@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Ayurved Mahavidyalaya, Sion, Mumbai |
Approved |
| Institutional ethics committee, Ayurved Mahavidyalaya, Sion, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G811||Spastic hemiplegia. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | SirobastiH, शिरोबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sharma A: 2013: Sushrut Samhita S.C.5/19: Choukhamba Sanskrit Prakashan: Varanasi, Procedure details: Daily in early morning, after Snehana and Svedana the patient will be advised to sit on a chair having height up to knee. The Shirobasti Yantra will be fixed on the head of patient above both ears. Shirobasti Yantra (cap) will be fixed tightly with the help of bandage. Internally it will be covered by the paste of black grain flour to avoid leakage.
Luke warm Tila Tail will be dropped in Shiropradeshi with the help of spoon at height up to 1 Angula. The oil will be kept warm by replacing cold o)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahavatvidhavansa rasa, Reference: 19. Rasendra Sarasangraha: 2021: A Textbook entitled by Ayurvediya Aushadhi Gunadharma Shastra: Gune G.: Chaukhamba Sanskrit Publication: New Delhi Pg no. 19, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshana jala), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ekangavir Rasa, Reference: Navare K: 2000: Nighanturatnakar: Vol II: Vatavyadhiadhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshana jala), Additional Information: - | | 4 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Shasri R, editor, Chakradatta of Chakrapanidatta, Niruhadhikara; Chapter 73, Verse 34-38. Delhi: Chaukhamba Sanskrit Publication,2000; 313., Procedure details: 40 gm Amlika and 20 gm of Guda will be mixed and will be kept in required quantity of water for whole night. In the next morning Amlika and Guda will be smashed thoroughly with hands and will be filtered. Then 10gmof Saindhava will be added to the semisolid mixture and will be mixed. Then about 30ml (Nirama) Tila Taila will be added drop by drop and will be mixed thoroughly. 160ml quantity of Gomutra will be added. Prakshep of Madanphala Churna mentioned in classics will be added. Above content )
| | 5 | Comparator Arm | Procedure | - | SirobastiH, शिरोबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sharma A: 2013: Sushrut Samhita S.C.5/19: Choukhamba Sanskrit Prakashan: Varanasi, Procedure details: Daily in early morning, after Snehana and Svedana the patient will be advised to sit on a chair having height up to knee. The Shirobasti Yantra will be fixed on the head of patient above both ears. Shirobasti Yantra (cap) will be fixed tightly with the help of bandage. Internally it will be covered by the paste of black grain flour to avoid leakage.
Luke warm Tila Tail will be dropped in Shiropradeshi with the help of spoon at height up to 1 Angula. The oil will be kept warm by replacing cold o)
| | 6 | Comparator Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Shasri R, editor, Chakradatta of Chakrapanidatta, Niruhadhikara; Chapter 73, Verse 34-38. Delhi: Chaukhamba Sanskrit Publication,2000; 313., Procedure details: 40 gm Amlika and 20 gm of Guda will be mixed and will be kept in required quantity of water for whole night. In the next morning Amlika and Guda will be smashed thoroughly with hands and will be filtered. Then 10gmof Saindhava will be added to the semisolid mixture and will be mixed. Then about 30ml (Nirama) Tila Taila will be added drop by drop and will be mixed thoroughly. 160ml quantity of Gomutra will be added. Prakshep of Madanphala Churna mentioned in classics will be added. Above content )
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Pakshavadh mentioned in Ayurvedic texts.
Patient having muscle power grade less than or equal to 3
Patients of Pakshavadh of duration not more than 5 years
Patient willing and able to participate in the study
Patients who have not participated in any research project in last 6 months
Patients of Pakshavadh having controlled hypertension systolic BP up to 140 mm of Hg and diastolic up to 90 mm of Hg and diabetes mellitus (BSL fasting up to 130 mg/dl and Post Prandial up to 180 mg/dl
|
|
| ExclusionCriteria |
| Details |
1.Patients of cerebral infraction due to atrial fibrillation, embolic stroke, carotid occlusion, cerebellar stroke and hemorrhagic stroke will be excluded.
2.Patients having seizers, hydrocephalous, pulmonary embolism, dysphagia, M.I., cardiac arrhythmia and septicemia will be excluded.
3.Patients who have lost bowel and bladder control.
4.Comatose and unconscious patients.
5.Patients having age < 21 years and > 70 years will be excluded.
6.Patients having intra cranial infection, encephalitis and meningitis etc.
7.Patient having trauma, cerebral tumour, cerebral abscess.
8.Patient with congenital heart diseases like POA, ASD, VSD and FOD.
9. Patients contraindicated for Abhyanga like skin diseases, infective disease etc. will be excluded.
10.Patients not fit for Basti.
11.Pregnant and lactating mothers.
12.Patients having acute progressive cerebral infarction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Mahavatavidvansa Rasa Vaitarana Basti Shirobasti in combination on Barthel Index & NIH Stroke Scale on Pakshavadh with special reference to cerebral infarction.
|
17th Day & 31st Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the effect of Mahavatavidhvansa Rasa, Vaitarana Basti & Shirobasti in combination with effect of Ekangavir Rasa,Vaitarana Basti & Shirobasti on Barthel Index And NIH Stroke scale on Pakshavadh with special reference to cerebral infarction.
2. Any new theoretical or clinical outcome will be noted. |
17th day & 31st day |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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 3 |
|
Date of First Enrollment (India)
|
21/10/2023 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Plan of work:
After Institutional Ethics
Clearance of APM’s Ayurvedic Mahavidyalaya Sion, Mumbai Screening
of Population will be done in OPD, IPD and casualty of APM’s Ayurvedic
Mahavidyalaya Sion and Government Ayurved Hospital & College Nagpur
institutes. In the Randomized control study
in each group 58 patients will include. If patient fulfil the criteria of
inclusion, subject would also give freedom to ask their questions and all
questions would answer. If he/ she agrees for participation in the study and
found fit to include then that patient will include in a study.
The Treatment will be given to
patients follow:
|
Group A (Control)
|
Group B (Trail)
|
|
Mahavatavidvansa
Rasa 125 mg twice a day in
PaschatBhakt Kala for
30 days
|
Ekangavir
Rasa 125 mg twice a day
in
Paschat
Bhakt Kala for 30 days
|
|
Kala Basti (Vaitarana Basti +Anuvasana with
Prasarini Tail) for 16 Consecutive days
|
Kala Basti (Vaitarana Basti +Anuvasana with
Prasarini Tail) for 16 Consecutive days
|
|
Shirobasti for 16 consecutive days
|
Shirobasti for 16 consecutive days
|
In
study Assessment of Scoring of Clinical features of Pakshavadh
(Mukhavakrata, Ruja and Hat Paksha), Barthel Index, NIH Stroke Scale, Muscle Power Grade, Muscle Tone and Investigational Parameters will
be taken on Zero day (B.T. Assessment), Mid
assessment on 17th day And Final
assessment of patient will be done on 31th day (A.T.
Assessment)
Medium
of Dissertation: The
study will be written in English and Sanskrit words will be used wherever
necessary.
Study
Design: Open Labelled Randomized Comparative Clinical Study
Duration
of Treatment: 30
days
Ethical
Clearance: Clearance
from Ethics Committee of A.P.M, s Ayurvedic Mahavidyalaya Sion, Mumbai
Study
Centre: OPD,
IPD of Kayachikitsa and Casualty of our institute and
periphery of Nagpur
Duration
of study:3 years from the date of approval of synopsis
Study
Population: All the patients of Pakshavadh attending OPD, IPD and Casualty of our Institute
will be considered in this study. Patients will be diagnosed on the
basis of CT scan of Brain (Plain) as described
earlier. Patients having signs and symptoms of Pakshavadh according to Ayurvedic
classics will be the main criteria for selection. All the patients of Pakshavadh with reference to cerebral infarction will be considered.
All the patients will be randomly selected irrespective of sex, religion, economic status and
educational status. For selection of the patient inclusion and exclusion
criteria will also be kept in
mind.
Sample
Size: sample size
evaluated is 58 in each group by using work done by Gundo J. entitled
“Randomized Comparative Study on Ekangavir
Rasa–Vaitarana Basti-Shirobasti in
Combination on Barthel Index and NIH Stroke Scale in Pakshavadh with special reference to Cerebral Infarction with 95% confidence interval and
80% as power of study. Considering 10% drop out 64 patients will be included in
each trial & control group. Hence total sample size of both groups will be
128 in study.
|