| CTRI Number |
CTRI/2021/01/030625 [Registered on: 20/01/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A research study to evaluate the effectiveness of nasal drops with siddharthaka agada arka (an Ayurvedic herbal distillate medicine ) in patients suffering from depressive disorders. |
|
Scientific Title of Study
|
An open label single arm clinical study on effectiveness of
siddharthaka agada arka pratimarsha nasya in kaphaja
unmada (depressive disorders) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirudh Sehra |
| Designation |
MD scholar department of Mano vigyan and Manas roga |
| Affiliation |
SDM college of ayurveda and hospital hassan |
| Address |
OPD number 8, SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
OPD number 8, SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8095862830 |
| Fax |
|
| Email |
pg19146@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
Professor and HOD department of Mano vigyan and Manas roga |
| Affiliation |
SDM college of ayurveda and hospital hassan |
| Address |
OPD number 8, SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
OPD number 8, SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
Professor and HOD department of Mano vigyan and Manas roga |
| Affiliation |
SDM college of ayurveda and hospital hassan |
| Address |
OPD number 8, SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
OPD number 8, SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| SDM college of ayurveda and hospital, bm road, thanniruhalla,
hassan
phone- 8172256460
email- college@sdmcahhassan.org |
|
|
Primary Sponsor
|
| Name |
SDM college of ayurveda and hospital hassan |
| Address |
SDM college of ayurveda and hospital, bm road, thanniruhalla, hassan phone- 8172256460 email- college@sdmcahhassan.org |
| Type of Sponsor |
Private medical college |
|
|
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 Anirudh Sehra |
Dept. of Manas Roga, OPD number- 08, SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
BM ROAD, THANNIRUHALLA
Hassan
KARNATAKA |
8095862830
pg19146@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F330||Major depressive disorder, recurrent, mild. Ayurveda Condition: Kaphaja unmada, (2) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: Kaphaja unmada, (3) ICD-10 Condition:F320||Major depressive disorder, singleepisode, mild. Ayurveda Condition: Kaphaja unmada, (4) ICD-10 Condition:F321||Major depressive disorder, singleepisode, moderate. Ayurveda Condition: Kaphaja unmada, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Siddharthaka agada arka |
Two drops siddharthaka agada arka in each nostril twice daily before food for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as per the criteria for mild and moderate depression as per ICD 10.
2. Age between 18 to 60 years.
3. Patients of either gender, irrespective of socioeconomic status.
4. Patients ready to sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients with other psychiatric disorders like Schizophrenia, Bipolar mood disorder, and substance abuse.
2. Patients with severe depressive disorder.
3. Pregnant women.
4. Patients with other systemic disorders like uncontrolled Hypertension, Diabetes mellitus, Tuberculosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the score of Hamilton depression scale, by the use of Siddharthaka agada arka pratimarsha nasya in the management of Kaphaja unmada (depressive disorders). |
outcomes will be assessed at baseline, 15 days and 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hamilton Depression scale |
15 days, 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is an open-labeled single-arm prospective clinical study to assess the effectiveness of Siddharthaka agada arka pratimarsha nasya, 2 drops to each nostril twice daily, before food in the age group 18 to 60 years, for 30 days in 30 patients of Kaphaja unmada (mild or moderate major depressive disorder) and will be conducted in one center in India. The secondary outcome will be the Hamilton depression scale after 30 days.
|