| CTRI Number |
CTRI/2020/09/027749 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
06/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EVALUATE THE EFFECT OF KUSHMANDA GHRITA IN TREATING SEIZURES |
|
Scientific Title of Study
|
EFFICACY OF KUSHMANDA GHRITA AS AN ADD ON DRUG IN
GENERALIZED TONIC CLONIC SEIZURES - A RANDOMIZED
CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRISHNA PRIYA G |
| Designation |
PG SCHOLAR |
| Affiliation |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA
SHAHAPUR
BELAGAVI
Belgaum
KARNATAKA
590003
India |
| Phone |
9400659966 |
| Fax |
|
| Email |
krishnapriyakedaram1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BASAVARAJ R TUBAKI |
| Designation |
HOD,DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA
SHAHAPUR
BELAGAVI
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BASAVARAJ R TUBAKI |
| Designation |
HOD,DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA |
| Address |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA
SHAHAPUR
BELAGAVI
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA |
| KLE AYURVEDA PHARMACY
KHASBAG BELAGAVI |
|
|
Primary Sponsor
|
| Name |
KLE UNIVERSITY |
| Address |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA
SHAHAPUR
BELAGAVI
KARNATAKA
590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| KRISHNA PRIYA G |
KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA |
OPD NUMBER -6
KAYACHIKITSA DEPARTMENT
Belgaum
KARNATAKA |
9400659966
krishnapriyakedaram1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTIEE ,KAHERs SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA ,KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KUSHMANDA GHRITA |
Kushmanda ghrita 10ml BD after food for 90 days in patients already under Levetiracetam 500mg BD
|
| Comparator Agent |
PLACEBO |
Placebo 500 mg BD After food for 90 days in patients already under Levetiracetam 500mg BD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Those with an established diagnosis of Epilepsy with generalized tonic-clonic seizures
2. Patients having occurrence of at least one seizure during previous three months
3. 18 to 60 years of age irrespective of gender and socio-economic status.
4. Patients having regular treatment since last 6 months and with Levetiracetam without
adjustments to medication for past 3 months. |
|
| ExclusionCriteria |
| Details |
1. Recent history of alcoholism and drug abuse.
2. Patients with uncontrolled diabetes mellitus, hypertension, congenital abnormalities, hepatic,
renal, cardiac or endocrine disease.
3. Mental retardation, infectious diseases of brain, vascular causes, toxic causes and metabolic causes of seizures.
4. Episode of status epilepticus within the past 3 months.
5. Psychiatric disorders like Schizophrenia, Psychosis, depression, suicidal thoughts etc
6. Pregnancy and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Chalfont-National Hospital seizure severity scale (NHS3)
2.Quality of Life in Epilepsy Inventory (QOLIE-31)
3.Changes in EEG before and after study |
30th day, 60th day & 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hamilton Anxiety Rating Scale |
30th day, 60th day & 90th day |
| Hamilton Depression Rating Scale |
30th day, 60th day & 90th day |
| The Pittsburgh Sleep Quality Index |
30th day, 60th day & 90th day |
| Columbia Suicide Severity Rating Scale |
30th day, 60th day & 90th day |
| Adverse event scales- UKU Scale |
30th day, 60th day & 90th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/12/2020 |
| Date of Study Completion (India) |
31/03/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Apasmara is defined as Apagama of Smrti associated with Tamah Pravesha, and Bibhatsa Chesta due to derangement of Dhi and Satva .Generalized tonic–clonic seizure is bilateral symmetric or sometimes asymmetric tonic contraction and then bilateral clonic contraction of somatic muscles, usually associated with autonomic phenomena and loss of awareness. These seizures engage networks in both hemispheres at the start of the seizure. Kushmaanda ghrita is one of the simple formulations described in Ashtanga Hridaya ,Uttarasthana, apasmara pratishedha and is widely practiced by Ayurvedic physicians as an alternative or complimentary therapy along with AED in their clinical settings. Kushmanda Ghrita has wide therapeutic activity like Deepana, Pachana, Akshepakahara, Sanjnasthapaka, Sroto Shodhaka, Smrti Vardhaka, Balya, Rasayana, Medhya etc. Hence it can have a potential role in the comprehensive management of Epilepsy. Initialy patients diagnosed with Generalized tonic clonic seizures are screened according to the inclusion and exclusion criteria .Selected patients will be randomly divided into Group A(20 patients )and Group B(20 patients) .Group A is given with Kushmanda ghrita 10ml BD after food and Group B with placebo capsules 500 mg BD for 90 days.Both group are under AED(levetiracetam 500mg BD) . Follow up will be done on 0th, 30th day, 60th day & 90th day. |