跳至主要内容
临床试验/CTRI/2024/01/062151
CTRI/2024/01/062151尚未招募3 期

“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 depression”

Dr Dafini David1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月2日最近更新:

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 pralāpa, bhrama, prajāgara, Å›oka ,kliṣṭamana, viṣāda,anavasthitacittatvā , Agnimandhya can be visualized at different symptom complexes in PPD and it is mentioned under sÅ«tikā rogas, vātaja nānātmaja vikāras and unmādaÅšatāvarÄ« is considered as kalinaÅ›ini dravyā it has smá¹›ti medā vardhaka & Bhuta Kalmasha Shapagni Properties.It has medā dhāraṇa Å›akti kāraka, Rasayana, agni ojo &stanya vardhana ,vātapitta hara action and it is considered as mahā Å›reṣṭa rasāyana*. Kṣīra*is indicated in pralāpa, bhrama, prajāgara and it has rasāyana & medhyā action  Kṣīrabala taila is indicated in 80 types of vāta rogahence its effect can be seen in viṣāda ,pralāpa ,asvapna ,anavasthitacittatvā]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 ÅšatāvarÄ« kṣīrapākafor 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 kṣīrapāka 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

发起方
Dr Dafini David
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Dafini David

Amrita School of Ayurveda,

研究点 (1)

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