| CTRI Number |
CTRI/2019/08/020756 [Registered on: 19/08/2019] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Exploring the role of Lasunadaya Ghrita pana and nasya in primary depression:A non randomized open clinical study. |
|
Scientific Title of Study
|
"Exploring the role of Lasunadya Ghrita Pana & Nasya in case of Primary Depression:A non randomized open clinical study". |
| Trial Acronym |
LGPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vandana tiwari |
| Designation |
MD SCHOLAR |
| Affiliation |
STATE AYURVEDIC COLLEGE LUCKNOW |
| Address |
DEPARTMENT OF KAYACHIKITSHA STATE AYURVEDIC COLLEGE LUCKNOW
DEPARTMENT OF KAYACHIKITSHA STATE AYURVEDIC COLLEGE LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9140808264 |
| Fax |
|
| Email |
vandana.tiwari125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Rastogi |
| Designation |
Reader (MD PHD) |
| Affiliation |
STATE AYURVEDIC COLLEGE LUCKNOW |
| Address |
DEPARTMENT OF KAYACHIKITSHA STATE AYURVEDIC COLLEGE LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415022955 |
| Fax |
|
| Email |
rastogisanjeev@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vandana tiwari |
| Designation |
MD SCHOLAR |
| Affiliation |
STATE AYURVEDIC COLLEGE LUCKNOW |
| Address |
DEPARTMENT OF KAYACHIKITSHA STATE AYURVEDIC COLLEGE LUCKNOW
DEPARTMENT OF KAYACHIKITSHA STATE AYURVEDIC COLLEGE LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9140808264 |
| Fax |
|
| Email |
vandana.tiwari125@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drug formation is done by me with the help of a local pharmacy. |
| Literary review is taken with the help of Institutional library. |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
DEPARTMENT OF KAYACHIKITSHA STATE AYURVEDIC COLLEGE LUCKNOW |
| Type of Sponsor |
Other [Individual] |
|
|
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 Vandana Tiwari |
State ayurvedic college lucknow and kgmu lucknow |
Department of kayachikitsha state ayurvedic college lucknow
Lucknow
UTTAR PRADESH |
9140808264
vandana.tiwari125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Conditional approval by Institutional Ethics Committee was given on 29/10/17 which is six month before enrolment of first patient. So please consider this |
Approved |
| Institutional Ethics Committee State Ayurvedic College Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, primary depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ESCITALOPRAM |
Dose:- 10mg HS, if patient having insomnia Zoltidem 10 to 20 mg HS, If patient having anxiety as pre-dominant symptom then etizolam .25 to 2mg HS
Duration: 28 days
Route of administration: Oral |
| Intervention |
LASUNADYA GHRITA |
DOSE- 5 gram in two divided doses with warm milk
Duration: 28 days
Route of administration: Oral & Nasal Instillation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed as primary depression as per ICD-10 criteria.patient having depression for not more than two years.patients willing to participate in the study voluntarily giving their informed consent.patient not having any other physical and mental co-morbidity considered as contraindication to the treatment. |
|
| ExclusionCriteria |
| Details |
Patient below 20 years and over 60 years.Patients having any other psychiatric co-morbidity.Patient having cognitive malfunctions due to substance abuse or due to age related dementia or mental retardation.Females in the stage of pregnancy or lactation.Patients having suicidal ideation or history of attempted suicide.Patients with marked irritable,unstable and violent behaviour.Patients allergic to any component of medication.Patients unable to take lasun or go-mutra due to their personal customs or belief.Patients not giving the consent for the study.Any condition where nasya is contraindicated. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hamilton Depression Scale |
Base line and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-36 |
Base line and Week 4 |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2018 |
| Date of Study Completion (India) |
06/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mental health is given foremost importance in ayurveda.Depression as a disease has many peculiarties.It may begin early at the age,may have multifaceted causes of which many may belong to the life style stressors,may results in huge personal, interpersonal, social and economical losses and may end up in suicidal attempts.It is in this purview,we are proposing to sceen Lasunadya ghrita for its therapeutic potential in cases of primary depression.Lasunadya ghrita is identified as a potential drug to unmad, a mental condition refered in ayurveda and having some resemblance to depression in context to it’s kaphaj subtype. Lasunadya ghrita is recommended to be used in such cases as an oral medication as well as in the form of instillation.For the purpose of present study we propose to have an enhanced effect on depression.The study is proposed to be non randomized open clinical trial having comparison of ayurvedic protocol with that of current psychiatric protocol.This clinical trial consisting of two groups namely interventional group and active comparator group.Intervention group is proposed to be given lasunadya ghrita nasya for 20 sitting comprising of approximately 5 sitting in a week.In addition to nasya this group is also recommended for lasunadya ghrita pana in a dose of 5 gram in a day in two divided with warm milk before meal for 4 weeks.Active comparator group is proposed to be given conventional pharmacotherapy for depression (Escitalopram 10 mg HS) as recommended by department of psychiatry kgmu Lucknow.In the study the total sample is considered to be 72 with approximate 36 sample in each group.For outcome assessment a significant reduction in HAMD score (less than 7) will be considered as remission to an individual patient. |