Ayurvedic clinical trial on Paralysis
- Conditions
- Spastic hemiplegia. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,
- Registration Number
- CTRI/2023/10/058622
- Lead Sponsor
- Ashish Arunkumar Thatere
- Brief Summary
**Plan of work:**
After Institutional EthicsClearance of APM’s Ayurvedic Mahavidyalaya Sion, Mumbai Screeningof Population will be done in OPD, IPD and casualty of APM’s AyurvedicMahavidyalaya Sion and Government Ayurved Hospital & College Nagpurinstitutes. In the Randomized control studyin each group 58 patients will include. If patient fulfil the criteria ofinclusion, subject would also give freedom to ask their questions and allquestions would answer. If he/ she agrees for participation in the study andfound fit to include then that patient will include in a study.
The Treatment will be given topatients 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**
Instudy 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 willbe taken on Zero day (B.T. Assessment), Midassessment on 17th day And Finalassessment of patient will be done on 31th day (A.T.Assessment)
**Mediumof Dissertation:**Thestudy will be written in English and Sanskrit words will be used wherevernecessary.
**StudyDesign:** Open Labelled Randomized Comparative Clinical Study
**Durationof Treatment:**30days
**EthicalClearance:** Clearancefrom Ethics Committee of A.P.M, s Ayurvedic Mahavidyalaya Sion, Mumbai
**StudyCentre:** OPD,IPD of *Kayachikitsa* and Casualty of our institute andperiphery of Nagpur
**Durationof study:**3 years from the date of approval of synopsis
**StudyPopulation:** All the patients of *Pakshavadh* attending OPD, IPD and Casualty of our Institutewill be considered in this study. Patients will be diagnosed on thebasis of CT scan of Brain (Plain) as describedearlier. Patients having signs and symptoms of *Pakshavadh* according to Ayurvedicclassics 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 andeducational status. For selection of the patient inclusion and exclusioncriteria will also be kept inmind.
**SampleSize:** sample sizeevaluated is 58 in each group by using work done by Gundo J. entitled“Randomized Comparative Study on *EkangavirRasa–Vaitarana Basti-Shirobasti* inCombination on Barthel Index and NIH Stroke Scale in *Pakshavadh* with special reference to Cerebral Infarction with 95% confidence interval and80% as power of study. Considering 10% drop out 64 patients will be included ineach trial & control group. Hence total sample size of both groups will be128 in study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (2)
A.P.Ms Ayurveda Mahavidyalaya, Sion, Mumbai
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurveda College And Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
A.P.Ms Ayurveda Mahavidyalaya, Sion, Mumbai🇮🇳Nagpur, MAHARASHTRA, IndiaDr Ashish Arunkumar ThaterePrincipal investigator9423406821ashish.thatere@gmail.com