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临床试验/CTRI/2025/04/084797
CTRI/2025/04/084797尚未招募4 期

Effectiveness Of Kalyanaka Ghritha In Mild To Moderate Postpartum Depression

Nanda Devi L Self funded1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年4月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
18
试验地点
1
主要终点
Change in postpartum depression assessed by using Edinburgh Postnatal Depression Scale (EPDS) score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 36.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in postpartum depression assessed by using Edinburgh Postnatal Depression Scale (EPDS) score

时间窗: Change in postpartum depression assessed by using Edinburgh Postnatal Depression Scale (EPDS) score after 4 weeks of medication

次要结局

未报告次要终点

研究者

发起方
Nanda Devi L Self funded
申办方类型
Other [Government Ayurveda College, Thiruvananthapuram]
责任方
Principal Investigator
主要研究者

Nanda Devi L

Government Ayurveda College, Thiruvananthapuram

研究点 (1)

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