| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G122||Motor neuron disease. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (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.)
| | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.anarine@icloud.com].
- 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.
- 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. |