| CTRI Number |
CTRI/2024/07/070647 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Brahmi ghritha and Counseling in improving the Geriatric Depression score in elderly. |
|
Scientific Title of Study
|
Effect of an Ayurvedic treatment protocol in the management of Late life depression-A Pre Post Test Study |
| 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 Sandeep S |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kayachikitsa, Amrita School of Ayurveda,Vallikavu,
Clappana P O, Kollam,Kerala,India-690525
Department of Kayachikitsa, Amrita School of Ayurveda,Vallikavu,
Clappana P O, Kollam,Kerala,India-690525
Kollam
KERALA
686605
India |
| Phone |
7907155901 |
| Fax |
|
| Email |
sandeenair98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devipriya Soman |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kayachikitsa, Amrita School of Ayurveda,Vallikavu,
Clappana P O, Kollam,Kerala,India-690525
Department of Kayachikitsa, Amrita School of Ayurveda,Vallikavu,
Clappana P O, Kollam,Kerala,India-690525
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
priya3656@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devipriya Soman |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kayachikitsa, Amrita School of Ayurveda,Vallikavu,
Clappana P O, Kollam,Kerala,India-690525
Department of Kayachikitsa, Amrita School of Ayurveda,Vallikavu,
Clappana P O, Kollam,Kerala,India-690525
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
priya3656@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda,Vallikavu,Clappana P O,Kollam,Kerala,India -690525 |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep S |
| Address |
Department of Kayachikitsa,Amrita school of Ayurveda,Vallikavu,Clappana P O,Kollam,Kerala-690525 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sandeep S |
Amrita School of Ayurveda |
Department of Kayachikitsa, Amrita school of Ayurveda,Vallikavu,Clappana P O,Kollam ,Kerala-690525
Kollam
KERALA |
7907155901
sandeenair98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F339||Major depressive disorder, recurrent, unspecified. Ayurveda Condition: KAPAJA-UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashta Churna, Reference: Ashtanga Hrudaya Chikitsa sthana Chapter 14, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -(2) Medicine Name: Brahmi Ghritha, Reference: Ashtanga Hrudaya Uttarasthana Chapter 6, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Warm milk), Additional Information: - with Satvavajaya chikitsa | | 2 | Comparator Arm (Non Ayurveda) | | - | NOT APPLICABLE | NOT APPLICABLE |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
GDS Score range 5-11.
Those who are willing to participate in this study and sign informed consent forms.
Patients with 5 or more of the 9 symptoms of major depressive disorder mentioned in DSM-5,persisting for a period of 2 weeks.
|
|
| ExclusionCriteria |
| Details |
Abnormal cognition and speech-causing difficulty in comprehension,expression and signing informed consent.
Previously diagnosed neurological and psychiatric diseases
Previously diagnosed with chronic infection
Individuals on medication having fasting Plasma glucose level above 126 mg/dl and post prandial 160 mg/dl.
Individuals on medication having Blood pressure above 150/90 mm hg.
Individuals on medication having Total Cholesterols level above 190mg/dl.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in depression scores as of Geriatric Depression Scale |
98 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of analysis based on PHQ-9 questionnaire
|
98 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Late life depression is one among the serious health concerns that are associated with comorbidity, impaired functioning, excessive use of health care resources and increased mortalities including suicides. In ayurveda sufficient research has not happened in this area. Based on various ayurvedic texts, this condition can be compared with Kaphaja Unmada. So here the treatment protocol comprises of administration of Brahmi ghrita after pachana dipana with Ashta churna for balance of tridoshas predominantly Vatha and kapha. Satvavajaya chikitsa which is considered as the main modality for mental and emotional distress by restraining mind from unwholesome objects is also integrated to the protocol. GDS 15 is the commonly used instrument for the screening of Late life depression with higher diagnostic accuracy. Hence the before and after changes of the score in 36 patients will be statistically analysed for a trial duration of 16 months. |