“An open label single arm clinical study to evaluate the combined effect of internal administration of satavari kshirapaka and kshirabala taila siropichu in mild to moderate post partum depressionâ€
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in mild-moderate symptoms associated with Post- Partum Depression assessed by using EPDS Scale,HDRS-17 Scale and ICD-10 Diagnostic Criteria
研究概览
简要总结
Post-Partum Depression (PPD) is defined as a major depressive episode in which symptoms can occur within a few months to a year after childbirthand it is characterized by insomnia, loss of appetite, anxiety and insecurity, emotional instability, mental confusion, loss of self-confidence, and suicidal ideation. The clinical presentations like pralÄpa, bhrama, prajÄgara, Å›oka ,kliá¹£á¹amana, viá¹£Äda,anavasthitacittatvÄ , Agnimandhya can be visualized at different symptom complexes in PPD and it is mentioned under sÅ«tikÄ rogas, vÄtaja nÄnÄtmaja vikÄras and unmÄdaÅšatÄvarÄ« is considered as kalinaÅ›ini dravyÄ it has smá¹›ti medÄ vardhaka & Bhuta Kalmasha Shapagni Properties.It has medÄ dhÄraṇa Å›akti kÄraka, Rasayana, agni ojo &stanya vardhana ,vÄtapitta hara action and it is considered as mahÄ Å›reá¹£á¹a rasÄyana*. Kṣīra*is indicated in pralÄpa, bhrama, prajÄgara and it has rasÄyana & medhyÄ action Kṣīrabala taila is indicated in 80 types of vÄta rogahence its effect can be seen in viá¹£Äda ,pralÄpa ,asvapna ,anavasthitacittatvÄ]which are the symptom complex experienced by Postpartum depression women.30 patients who fulfil the inclusion criteria will be selected from OPD and IPD Amrita Ayurveda Hospital. Written informed consent will be taken from patients and detailed history of the patient will be taken with a case proforma. EPDS Questionnaire will be given to all the Post-Partum women who were taking consultation in hospital. The EPDS scores are being calculated. Women with EPDS score >13 will be enrolled in the study. Written informed consent will be taken from patients and detailed history of the patient will be taken with a case proforma. Baseline data, HDRS-17 score, ICD-10 scores are calculated to categorize in mild - moderate depression and to exclude the high-risk cases. Each patient is advised for treatment with Kṣīrabala taila Åširopicufor 7 days & Internal administration of ÅšatÄvarÄ« kṣīrapÄkafor 30 days. Based on Astanga Sangraha Reference,ask the patient to prepare Ksheerapaka . First Kashaya of the drug will be prepared and filtered. To that equal quantity of milk is added and boiled till the milk part remains .2 Pala (96 ml) of kṣīrapÄka is advised to take in an empty stomach for 30 days.Åširopicu procedure will be explained in detail to the patient and advised to do Åširopicu 1 hour before sleep with a duration of 30 minutes for 7 days and after the procedure wiped off with a dry cloth. Procedure will be continued for 7 days. First Post assessment will be done with EPDS on the day 8 after completing the Åširopicu . Second Post assessment will be done after 30 days and the improvement in mild- moderate symptoms will be evaluated through EPDS scale, HDRS-17 & ICD-10 diagnostic criteria. Once the endpoint is reached, the patient is censored from the study.
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
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Age between eighteen to fortyyears, primi or multigravida without labour complications, Epds score greater than 13, hamitons score greater than eight and eighteen, patients from four weeks to tenmonths are included.
排除标准
- •EPDS score less than 13, Hamiltons score greater than 18, ICD10 diagnostic criteria with severe episodes are excluded, Previous history of psychiatric disorder, under antidepressent medications, Active suicidal,homicidal and infanticide thoughts during prescreening.
结局指标
主要结局
Improvement in mild-moderate symptoms associated with Post- Partum Depression assessed by using EPDS Scale,HDRS-17 Scale and ICD-10 Diagnostic Criteria
时间窗: 8th day and 30th day
次要结局
未报告次要终点
研究者
Dr Dafini David
Amrita School of Ayurveda,
