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CTRI Number  CTRI/2025/04/084797 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effectiveness of oral intake of Kalyanaka Ghritha in reducing mild to moderate Post Partum Depression 
Scientific Title of Study   Effectiveness Of Kalyanaka Ghritha In Mild To Moderate Postpartum 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  Nanda Devi L 
Designation  PG Scholar, Dept Of Prasutitantra And Striroga 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Room No. 2, Department of Prasutitantra And Striroga, Government Ayurveda College & Hospital, Thiruvananthapuram
Sree Pankaj, T.C.28/2662(1), Chettikulangara, Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India 
Phone  08547111763  
Fax    
Email  drlnandadevi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Asha Sreedhar  
Designation  Professor & HOD, Dept Of Prasutitantra And Striroga 
Affiliation  Government Ayurveda College, Kannur  
Address  Room No. 2, Government Ayurveda College & Hospital, Kannur

Thiruvananthapuram
KERALA
670502
India 
Phone  9447893112  
Fax    
Email  drashaajith@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Asha Sreedhar 
Designation  Professor &HOD, Dept Of Prasutitantra And Striroga 
Affiliation  Government Ayurveda College, Kannur 
Address  Room No. 2, Government Ayurveda College, Pariyaram, Kannur

Kannur
KERALA
670502
India 
Phone  9447893112  
Fax    
Email  drashaajith@gmail.com  
 
Source of Monetary or Material Support  
Dr. Nanda Devi. L (Self - funded), PG Scholar, Dept. Of Prasutitantra And Striroga, Government Ayurveda College, Thiruvananthapuram, Pin- 695 001, Kerala, India Sree Pankaj, KRA A36, Chettikulangara, Thiruvananthapuram, Pin- 695 001, Kerala, India 
 
Primary Sponsor  
Name  Nanda Devi L Self funded 
Address  PG Scholar, Dept. Of Prasutitantra And Striroga, Government Ayurveda College, Thiruvananthapuram, Pin- 695 001, Kerala, India 
Type of Sponsor  Other [Government Ayurveda College, Thiruvananthapuram] 
 
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 
Dr Nanda Devi L  Women & Child Hospital, Poojappura, Thiruvananthapuram  Dept. Of Prasutitantra And Striroga, OP No.1, Government Ayurveda College, Thiruvananthapuram
Thiruvananthapuram
KERALA 
08547111763

drlnandadevi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instiitutional Ethics Committee, Government Ayurveda College, Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F53||Puerperal psychosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kalyanaka Ghrithm  24 ml in two equally divided doses (12 ml in the morning and 12 ml in the evening) 1 hr before food with hot water as anupana for one month. 
Comparator Agent  Not Applicable  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  36.00 Year(s)
Gender  Female 
Details  Participants of the age group 19 to 36 years, from 4 weeks till one year of delivery, clinically diagnosed with postpartum depression, diagnosed as per ICD10 guidelines 
 
ExclusionCriteria 
Details  Participants who have a history of medications for Bipolar diseases, Epilepsy, Schizophrenia, Phobia, OCD
Postpartum psychosis, Uncontrolled systemic and chronic illness
Known cases of Malignancy or terminal illness
•Participants having suicidal / homicidal thoughts
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in postpartum depression assessed by using Edinburgh Postnatal Depression Scale (EPDS) score   Change in postpartum depression assessed by using Edinburgh Postnatal Depression Scale (EPDS) score after 4 weeks of medication  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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 4 
Date of First Enrollment (India)   25/04/2025 
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 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  

Postpartum depression is a disabling but treatable mood disorder that represents one of the most common complications of child bearing with a global prevalence of 17.7%. Major symptoms include depressed mood to a degree that is definitely abnormal for the individual, present for most of the day and almost every day, largely uninfluenced by circumstances, and sustained for at least 2 weeks, loss of interest or pleasure in activities those are normally pleasurable and reduced energy or increased fatiguability. Kashyapa in Sutikopakramaniya Adhyaya mentions Unmada as one among the 64 sootikarogas. Caraka in Nidana Sthana mentions people with disturbed or annoyed minded as vulnerable to Unmada. A postpartum woman has more chances of this mental state due to a sudden hormonal, physical, emotional and social changes after having a baby. In the Yuktivyapasraya chikitsa of Unmada, the prior line of treatment mentioned by Acharya Caraka is Snehapana.  Hence Kalyanaka Ghritha mentioned in Unmada Chikitsa has been chosen for the study. Study design is pre and post interventional study with a sample size of 18. Participants of age group 19 – 36 years, from 4 weeks till one year of delivery, selected from the OPD of Prasutitantra and Streeroga, Govt. Ayurveda College, Thiruvananthapuram, diagnosed with depression based on ICD 10 Criteria will be included in the study. Those who have a history of medications for Bipolar diseases, Epilepsy, Schizophrenia, Phobia, OCD, Postpartum psychosis, uncontrolled systemic and chronic illness, known cases of malignancy or terminal illness, participants having suicidal/homicidal thoughts and snehapana anarhas will be excluded. Participants will be assessed through Edinburgh Postnatal Depression Scale, Case Proforma, Pre-designed questionnaire and Lab investigations. The study period is 18 months. For each participant, prepared medicine will be dispensed through OPD in 200gm container and instructions will be given to the patients to have 24 ml of ghritha in two equally divided doses (morning and evening) 1 hour before food with hot water as anupana for 30 days. Assessments will be done before treatment (0th day), 31st day and followed up on the 61st day using Edinburgh Post Natal Depression Scale. Data obtained will be statistically analysed and summarised to arrive at conclusions.

 
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