| CTRI Number |
CTRI/2021/01/030168 [Registered on: 01/01/2021] Trial Registered Prospectively |
| Last Modified On: |
31/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to find the add-On Effect of Selected Ayurvedic Treatment Protocol in Focal Seizures Evolving to Generalized Seizures |
|
Scientific Title of Study
|
Add-On Effect of Selected Ayurvedic Treatment Protocol in Focal Seizures Evolving to Generalized Seizures-A Non Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidhya M Sanker |
| Designation |
PG Scholar |
| Affiliation |
VPSV Ayurveda College |
| Address |
Dr Vidhya M Sanker
PG Scholar
Manovigyan avum Manasroga
Department of Kayachikitsa
VPSV Ayurveda College
Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
7025841336 |
| Fax |
|
| Email |
vidhyasanker90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJithesh M |
| Designation |
Professor and HOD |
| Affiliation |
VPSV Ayurveda College |
| Address |
Dr Jithesh M
Professor and HOD
Department of Kayachikitsa
VPSV Ayurveda College
Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9447882885 |
| Fax |
|
| Email |
drjitheshm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJithesh M |
| Designation |
Professor and HOD |
| Affiliation |
VPSV Ayurveda College |
| Address |
Dr Jithesh M
Professor and HOD
Department of Kayachikitsa
VPSV Ayurveda College
Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9447882885 |
| Fax |
|
| Email |
drjitheshm@gmail.com |
|
|
Source of Monetary or Material Support
|
| VPSV Ayurveda college,kottakkal |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Vidhya M Sanker |
IPD VPSV AYURVEDA COLLEGE KOTTAKKAL & GARIM KOTTAKKAL |
IPD VPSV AYURVEDA COLLEGE KOTTAKKAL & GOVT. AYURVEDA RESEARCH INSTITUTE FOR MENTAL DISEASES KOTTAKKAL
MALAPPURAM
Malappuram
KERALA |
7025841336
vidhyasanker90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, VPSV Ayurveda college , Kottakkal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G402||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures. Ayurveda Condition: APASMARAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Observation-(observing the effect of antiepileptic drugs they are taking already) |
Observing the effect of Anti Epileptic Drugs. |
| Intervention |
Treatment protocol |
.Rukshana with takrapana (1.5l takra with 5gm vaiswanarachurna intake frequently) 2.Snehapana with kushmandaswarasa ghrita (starting from 30ml in arohanamatra upto samyaksnigdada)3.Abhyanga and ushmasweda with dhanwantaram thaila (100ml E/A)4.Virechana with avipathy churna-30gm 5.Samanam with Kushmandaswarasa ghrita(10ml-0-10ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.diagnosed cases of focal seizures evolving to generalized seizures
2.participants on AED for the last one year with at least one seizure a month for the last three months
3. those who are fit for snehapana and sodhana
4.patients willing to give written consent |
|
| ExclusionCriteria |
| Details |
1.with a recent history of alcoholism or drug abuse
2.pregnancy or lactation
3.with symptoms of any other progressive brain disorders or comorbid psychiatric disorders
4.those having cardiovascular diseases, chronic hepatic diseases , renal dysfunction , thyroid dysfunction
5.status epileptics
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will be assessed by using Epilepsy severity assessment chart used in previous studies in our department |
0th day ,15th day,30th day , 45th day,60th day and 75th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the Quality Of Life In Epilepsy patients |
0th day and after treatment |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
04/01/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Non-randomized controlled trial to assess the add-on effect of selected Ayurvedic protocol in focal seizures evolving to generalized seizures in 2 groups of 16 participants in trial and 16 in controlled group .The selected protocol have promising results in seizure disorders as per the experiences from practices of the same. The intervention is for 45 days which includes15 days of IPD treatment and 30 days of samanaoushadhi and a follow up after 30 days in trial group and the controlled group is observed with the regular AEDs they are taking and the outcome will be measured using epilepsy severity assessment charts and QOLIE Charts. |