| 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
|
|
|
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
|
|
|
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. |