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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 Ä€yurveda treatment modality in postpartum depression  
Scientific Title of Study   Effect of selected Ä€yurveda 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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F53||Puerperal psychosis. Ayurveda Condition: Kaphaja Unmada,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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. Ä€yurveda have the potential to improve the symptoms of mood disorders especially Postpartum depression. A combination of Drākṣādi Phāṇṭam and AÅ›vagandha – Aparājita – Vaca cÅ«rņa has been in use in Manaśśānti 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 Drākṣādi Phāṇṭam will be given at 6am and 6pm- with Sita as anupāna and 3gm of AÅ›vagandha – Aparājita – Vaca cÅ«rņa (in the ratio 2:2:1) will be given after breakfast and dinner with honey as anupāna 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.

 
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