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CTRI Number  CTRI/2025/01/079100 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 13/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Panchakarma treatment in paralysis. 
Scientific Title of Study   A clinical study on effectiveness of Panchakarma along with samana in cikitsa in Paksaghata w.s.r to Hemiplegia 
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 Rutvaben B Amaliyar 
Designation  P G Scholar ( Panchakarma) 
Affiliation  J S Ayurveda Mahavidyalaya, Nadiad 
Address  Department of Panchakarma, J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital, Nadiad, Kheda.

Kheda
GUJARAT
387001
India 
Phone  7567457269  
Fax    
Email  rutvabhimjibhai@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaimin R Patel 
Designation  Professor of Department of Panchakarma 
Affiliation  J S Ayurveda Mahavidyalaya, Nadiad 
Address  Department of Panchakarma, J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital, Nadiad, Kheda.

Kheda
GUJARAT
387001
India 
Phone  9427859535  
Fax    
Email  vd.jaimin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaimin R Patel 
Designation  Professor of Department of Panchakarma 
Affiliation  J S Ayurveda Mahavidyalaya, Nadiad 
Address  Department of Panchakarma, J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital, Nadiad, Kheda.

Kheda
GUJARAT
387001
India 
Phone  9427859535  
Fax    
Email  vd.jaimin@gmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurved teaching pharmacy of J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital, college road, Nadiad, Kheda, Gujarat. 387001 
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  Department of Panchakarma, J S Ayurveda Mahavidyalaya, college road, Nadiad -387001 
Type of Sponsor  Private medical college 
 
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 Rutvaben B Amaliyar  P D Patel Ayurveda Hospital  Department of Panchakarma, J S Ayurveda MahaVidhyalaya, College road, Nadiad 387001
Kheda
GUJARAT 
7567457269

rutvabhimjibhai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MAM UNIVERSITY-NADIAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: charak samhita, Procedure details: sarvanga abhyanga with atibala taila will be done in the morning)
(1) Medicine Name: atibala, Reference: bhavprakash nighantu, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 34 Days
2Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: charak samhita, Procedure details: after abhyanga ,sarvanga baspa svedana will be given to patient in morning)
(1) Medicine Name: nirgundi patra, Reference: bhavprakash nighantu, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: od, Duration: 34 Days
3Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charak samhita, Procedure details: on 3rd day of sarvanga abhyanga & svedan,virecana will be done in morning)
(1) Medicine Name: dindayal churna, Reference: bhaishajya sara sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: eranda sneha, Reference: bhaishajyasara sangraha, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days
4Intervention ArmProcedure-SirobastiH, शिरोबस्तिः (Procedure Reference: ashtang hridaya, Procedure details: after shodhana karma shirobasti will be done in afternoon.)
(1) Medicine Name: atibala taila, Reference: Bhavprakash niganthu, Route: Topical, Dosage Form: Taila, Dose: 400(ml), Frequency: od, Duration: 30 Days
5Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: astanga hridaya, Procedure details: after shodhana karma from next day nasya karma will be done with Atibala Taila (8-8drops each nostril))
(1) Medicine Name: Atibala taila, Reference: bhavprakash niganthu, Route: Nasal, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 30 Days
6Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charaka samhita, Procedure details: After virecana karma niruha basti will be given to patient in morning.)
(1) Medicine Name: dashamool kwatha, Reference: charak samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 1 Days
7Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak samhita, Procedure details: marta basti will bw given to pateint in the evening after food.)
(1) Medicine Name: atibala taila, Reference: bhavprakash nigantu, Route: Rectal, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 30 Days
8Intervention ArmDrugClassical(1) Medicine Name: balabija churna, Reference: bhavprakash niganthu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -
(2) Medicine Name: aswagandha churna, Reference: bhavprakash niganthu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(3) Medicine Name: balamool kwatha, Reference: bhavprakash niganthu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(4) Medicine Name: atibalataila, Reference: bhavprakash niganthu, Route: Oral, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: balamool kwatha), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients clinically examined and diagnosed with sign and symptoms of Paksaghata (Hemiplegia) and confirmed neurological examination.
Patients stable after the stroke condition and not chronic more than 5 years. 
 
ExclusionCriteria 
Details  Patients suffering from hemiplegia with severe systemic illnesses like uncontrilled diabetes mellitus, and/or any other associated comorbidity.
Patient contraindicated for Virechana, Basti, Nasya karma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the sign and symptoms along with score of FUGL-MAYER assessment of physical performance  Baseline, after discharge and follow up every week upto 4 week 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/02/2025 
Date of Study Completion (India) 01/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

In this part of the dissertation, an overall review of the research work has been undertaken, and a conclusive statement is made regarding the study.


 
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