| CTRI Number |
CTRI/2021/11/037769 [Registered on: 02/11/2021] Trial Registered Prospectively |
| Last Modified On: |
01/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of selected Āyurveda treatment modality in postpartum depression
|
|
Scientific Title of Study
|
Effect of selected Āyurveda treatment modality in mild to moderate Postpartum Depression –
Single group Pretest–Posttest Design
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RINISHA M |
| Designation |
PG Scholar |
| Affiliation |
VPSV Ayurveda College, Kottakkal |
| Address |
Manovigyan Avum Manasroga
Department of Kayachikitsa
VPSV Ayurveda College
Kottakkal
Edarikode
Malappuram KERALA 676501 India |
| Phone |
9446359115 |
| Fax |
|
| Email |
drrinishasujeesh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Satheesh K MD Ay |
| Designation |
Associate Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Dr. Satheesh. K. MD (Ay)
Associate Professor
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal Malappuram KERALA 676501 India |
| Phone |
9249993257 |
| Fax |
|
| Email |
drsatheeshpdm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Satheesh K MD Ay |
| Designation |
Associate Professor |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Dr. Satheesh. K. MD (Ay)
Associate Professor
Department of Kayachikitsa
VPSV Ayurveda College Kottakkal
Malappuram KERALA 676501 India |
| Phone |
9249993257 |
| Fax |
|
| Email |
drsatheeshpdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manovigyan Avum Manasroga
Department of Kayachikitsa
VPSV Ayurveda College
Kottakkal
Edarikode
Malappuram |
|
|
Primary Sponsor
|
| Name |
Rinisha M |
| Address |
PG Scholar
Manovigyan Avum Manasroga Department of Kayachikitsa
V. P.S.V Ayurveda College Kottakkal |
| 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 |
| Rinisha M |
VPSV Ayurveda College |
Manovigyan Avum Manasroga
Department of Kayachikitsa
VPSV Ayurveda College
Edarikkode
Kottakkal
Malappuram Malappuram KERALA |
9446359115
drrinishasujeesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F53||Puerperal psychosis. Ayurveda Condition: Kaphaja Unmada, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi phantam, Reference: Ashtangahrdayam Jwara chikitsadhikaram, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: sitha), Additional Information: Combination of Aswagandha, Aparajita, Vacha in the ratio 2:2:1 in a dose of 3 gm bid with honey for 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
36.00 Year(s) |
| Gender |
Female |
| Details |
• Diagnosed cases of Mild to Moderate Postpartum depression as per ICD-10 diagnostic criteria
•Age group: 19-36 years
•All kinds of deliveries
•Those who are not under any psychiatric medication
•Those willing to give written consent
|
|
| ExclusionCriteria |
| Details |
•Known cases of Diabetes Mellitus, Cardiovascular disease, Hypertension,, thyroid dysfunction
•Other co-morbid psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of selected Ayurveda treatment modality in mild to moderate Postpartum depression |
45 days intervention and 60th day follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life of the subjects with mild to moderate Postpartum depression |
2 months |
|
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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)
|
02/11/2021 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mood disorders are a major public health problem and
are associated with considerable burden of disease, suicides, physical
comorbidities, high economic costs and poor quality of life. Depression is a
serious mood disorder. Postpartum depression is a disabling but treatable
mental disorder that represents one of the most common complications of child
bearing with a global prevalence of 18.6%. Major symptoms include hopelessness,
helplessness, persistent sadness, irritability, low self-esteem, mood changes,
loss of pleasure in activities etc. Postpartum depression has increased risks
of impaired emotional, social and cognitive development in the child. Āyurveda have the potential to improve the symptoms of mood disorders
especially Postpartum depression. A combination of DrÄká¹£Ädi PhÄṇá¹am and AÅ›vagandha
– AparÄjita – Vaca cÅ«rņa has been in use in ManaśśÄnti OPD of VPSV Ayurveda College Hospital Kottakkal, since
many years which is found to be very effective but a scientific research data
regarding this is currently unavailable. Hence this study is planned.
Twenty six participants satisfying the inclusion
criteria will be selected from the OPD of VPSV Ayurveda College Kottakkal and
Government Ayurveda Research Institute for Mental Diseases Kottakkal by
consecutive sampling. For each participant, 50ml each of DrÄká¹£Ädi PhÄṇá¹am will be given at 6am and 6pm- with Sita as anupÄna and 3gm of AÅ›vagandha
– AparÄjita – Vaca cÅ«rņa (in the ratio 2:2:1) will be given after breakfast
and dinner with honey as anupÄna for
45 days and will be followed up after 60 days. Assessments will be done
before treatment, 15th day,
30th day, 46th day
and followed up on the 60th day using Hamilton Depression Rating
Scale. Quality of life will be assessed
using WHOQOLBREF scale before treatment, on 46th day and
follow up on 60th day. Data obtained will be statistically analyzed
using appropriate tests and will be presented in the form of a dissertation. |