| CTRI Number |
CTRI/2024/03/063884 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Panchagavya Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression. |
|
Scientific Title of Study
|
Randomized Control Trials of Panchagavya Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression. |
| 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 Pramod Sakharam Mandalkar |
| Designation |
Ph D Scholar |
| Affiliation |
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center, Astha |
| Address |
Department of Panchakarma
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali
Sangli MAHARASHTRA 416301 India |
| Phone |
9604633832 |
| Fax |
|
| Email |
vdpramod31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pramod Sakharam Mandalkar |
| Designation |
Ph D Scholar |
| Affiliation |
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center, Astha |
| Address |
Department of Panchakarma
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali
Sangli MAHARASHTRA 416301 India |
| Phone |
9604633832 |
| Fax |
|
| Email |
vdpramod31@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Alaknanda Kulkarni |
| Designation |
Ph D Guide |
| Affiliation |
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center, Astha |
| Address |
Department of Panchakarma
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali
Sangli MAHARASHTRA 416301 India |
| Phone |
9860359489 |
| Fax |
|
| Email |
vdalaknandakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma
Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali |
| Department of Panchakarma SMBT Ayurved College and Hospital Dhamangaon Tal Igatpuri Dist Nashik |
| GMP Certified Pharmacy |
|
|
Primary Sponsor
|
| Name |
Dr Pramod Sakharam Mandalkar |
| Address |
Flat no 203 Blue Building Dream Citi Cooperative Housing Society Nashik Road Nashik 422006 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Mandalkar |
Honorable Annasaheb Dange Ayurved Medical College and Research Center Astha |
OPD No 09 Department of Panchakarma Sangli MAHARASHTRA |
9604633832
vdpramod31@gmail.com |
| Dr Pramod Mandalkar |
SMBT Ayurved College and Hospital Dhamangaon Tal Igatpuri |
OPD No 13 Department of Panchakarma Nashik MAHARASHTRA |
9604633832
vdpramod31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Annasaheb Dange Ayurved Medical College and Research Center Astha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as per the criteria for Mild and Moderate depression as per ICD-10, Indicated for Nasya Karma procedure, Patient is not allowed other medications for depression during study period
|
|
| ExclusionCriteria |
| Details |
Patients below age 18 and above 50 years, Contraindicated for Nasya Karma, Patients with other psychiatric disorders and major depressive disorder, Patients with Chronic illness like Cancer, Hypertension, Diabetes Mellitus and Thyroid Disorders, Patients with suicidal tendency or thoughts and Organic Mood disorders, Chronic drug abuse, Chronic Alcoholic
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Panchagavya Ghrita Nasya and Hingwadi Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review of Vishada according to Ayurved and Modern aspects.
To review of Nasya Karma according to Ayurved and Modern aspects.
To study the Adverse Drug Reaction if observed.
To evaluate the probable mode of action of Panchagavya Ghrita Nasya. |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
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)
|
31/03/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The
population-based study from India to report on depression shows that the
prevalence of depression was 15.1%. India is home to an estimated 57 million
people (18% of the global estimate) affected by depression. Considering
the huge burden and impact of depression and its importance as public health
concern in developing and developed world, the World Health Organization
declared depression: Let’s Talk, as the theme of World Health day on April 07,
2017 and lead a yearlong campaign on depression domains. There is also a need to study the course of depressive disorders
in India so as to determine the need and duration of continuation treatment.
The present study Randomized Control Trials will be carried out with aim to evaluate the efficacy of Panchagavya Ghrita Nasya in Vishada with special reference to Mild
to Moderate Depression. For present study patients fulfilling the diagnostic
criteria of Mild to Moderate
Depression (ICD-10), between the age group of 18 yrs to 50 yrs with irrespective
of Gender, religions, socioeconomic status etc. By
using Sample size formula; Sample size found 57, so that 57
patients will be taken for study in each group. Total 114 numbers of patients
will be selected and randomly divided into two groups, named as Group-A (Trial
Group) and Group-B (Control Group) with Single Blind. Panchagavya Ghrita Nasya and Hingwadi
Ghrita Nasya will be carried out in Group-A (Trial Group) patients and
Group-B (Control Group) patients respectively. Trial and Control Drugs will be purchase from GMC certified
pharmacy. Both drugs will be administered through nasal route
with 3ml quantity in each nostril at morning hours continuous for 14 days. All
SOP of Nasya Karma will be strictly followed during and after treatment. All the
findings will be entered in Case Record Form (CRF) and for better understanding
tabulation and graphical presentation will be done. Observations will be drawn on Before Treatment (0th day), During Treatment (At 7th day), After
Treatment (At 14th day) and Weekly Follow-up after completion of
treatment (At 21th day). Result of study will be calculated
statistically with appropriate statistical method. Result
will be drawn on basis of Criteria of assessment and Statistical analysis.
Discussion will be done on the basis of observations and result obtained during
the treatment. Summary will be drawn and whole thesis work will be summarized.
Conclusion will be draw strictly on basis of statistical Analysis and will be
unbiased. |