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CTRI Number  CTRI/2024/05/067257 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of Yapana Basti, Shashti Shali Pinda Swedana and Nasya Karma in Amyotrophic Lateral Sclerosis (Vatavyadhi). 
Scientific Title of Study   “A Randomized Comparative Clinical Study to Evaluate the Efficacy of Yapana Basti and Shashti Shali Pinda Swedana with and without Nasya Karma followed by Shaman in the Management of Sarvanga Vatavyadhi with special reference to Amyotrophic Lateral Sclerosis.” 
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 Avvinish Narine 
Designation  Ph.D Candidate 
Affiliation  National Institute of Ayurveda, (DU), Jaipur. 
Address  Room number 111, First Floor, Department of Panchkarma, National Institute of Ayurveda (DU), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9971216140  
Fax    
Email  dr.anarine@icloud.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  Professor and Head of Department 
Affiliation  National Institute of Ayurveda, (DU), Jaipur. 
Address  Room number 114, First Floor, Department of Panchkarma, National Institute of Ayurveda (DU), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone    
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avvinish Narine 
Designation  Ph.D Candidate 
Affiliation  National Institute of Ayurveda, (DU), Jaipur. 
Address  Room number 111, First Floor, Department of Panchkarma, National Institute of Ayurveda (DU), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9971216140  
Fax    
Email  dr.anarine@icloud.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda (Deemed University), Jaipur, Rajasthan, Bharat. 302002. 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar Singh Gate, Amer Road, Jaipur. 
Type of Sponsor  Government 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 Avvinish Narine  National Institute of Ayurveda (Deemed University)  Panchkarma Department, OPD Number 2, Main Hospital Building, Jorawar Singh Gate, Amer Road, Jaipur.
Jaipur
RAJASTHAN 
9971216140

dr.anarine@icloud.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G122||Motor neuron disease. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ch Si 12/16(9), Procedure details: - Sarvanga Shashtika Shali Pinda Swedana will be performed along with Yapana Basti for 16 days according to Kala Basti schedule. - Followed by Trisati Prasarini Taila 10 ml BD for 15 days.)
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Su Chi 40/21-29, Procedure details: - Sarvanga Shashtika Shali Pinda Swedana will be performed along with Yapana Basti for 16 days according to Kala Basti schedule. - Nasya Karma will be performed for 14 days using Trisati Prasarini Taila; 6 drops in each nostril. - Followed by Trisati Prasarini Taila 10 ml BD for 15 days.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  (a) Diagnosed cases of Amyotrophic Lateral Sclerosis, having less than five years onset.
(b) Patients will be selected from the age group of 20-60 years, irrespective of sex, religion
and occupation etc.
(c) Patients of ALS who are willing to participate in an interventional study.
(d) Patients willing to sign the informed consent form 
 
ExclusionCriteria 
Details  (a) Patients with brain lesions.
(b) Patients with systemic or endocrine disorders.
(c) Patients with severe respiratory distress.
(d) Age less than 20 years and more than 60 years.
(e) Patients having other neurological degenerated diseases.
(f) Patients not willing to sign the informed consent form. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes will be assessed on the basis of the ALS Functional
Rating Scale- Revised (ALSFRS-R) and Norris scale. 
Day 0 (Baseline), Day 30, and Day 75 (Follow-up) 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in other symptoms of Amyotrophic Lateral Sclerosis.  75days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/06/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.anarine@icloud.com].

  6. For how long will this data be available start date provided 31-01-2027 and end date provided 31-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Introduction:
Since the beginning of time, sickness and man have been rivals. Man has waged an unrelenting war against his enemies in an effort to protect his health, treat sickness, alleviate suffering and extend life despite disabilities. Ayurvedic treatmens, particularly panchkarma have become increasingly popular as a result of the strong basis of the holistic approach upon which the entire edifice of Ayurveda is based. In order to provide some sort of symptomatic and supportive treatment fo maintaining the quality of life, motor neuron diseases are a group of prrogressive neurological disorders that call for a variety of applicaations, modalities and interventions, including occupational therapy, physical and speech therapies.
Shodhana and Shamana are the two primary therapeutic methods used in Ayurveda. Shodhana therapy is regarded as the best since it aids in the entire eradication of vitiatied Doshaa, preventing the ailment from reoccurring like uprooting weeds by the roots. In order to restore internal equilibrium. The Motor neurons of the CNS, particularly those in the pyramidal and extrapyramidal tracts, degenerate in MND. MND patients may benefit from Panchkarma treatment. One Panchkarma treatment, Sarvanga Shashti Shali Pinda Swedana targets particulaarly Vata predominant illnesses. Sarvanga Shashti Shali Pinda Swedana performed over the whole body is helpful for MND related muscle weakness. Basti is regarded as the most effective shodhana procedure due to its broad applicability and mulitfaceted therapeutic effects. Acharyas refer to it as Ardha Chikitsa in Ayurveda and it is relevant to all. A type of Basti called Yapana Basti possess Snehana and Shodhana qualities. It is indicated in both healthy and unhealthy situations. Yapana Basti is thought to have Rasayana propertiees and to build up the muscles.
Need for Study: MND is one of the most severe disorders of the nervous system that causes severe problems for those who have it, on a social, personal and financial level. Other than supporting measures, no medical system has yet developed an effective management strategy. Thus this study aims to evaluate the treatment of Ayurveda in the disease.
 
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