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临床试验/CTRI/2020/01/022935
CTRI/2020/01/022935已完成不适用

CLINICAL EVALUATION OF THE EFFICACY OF SOUBHAGYA SHUNTHI PAKA AND DASAMOOLARISTA IN SUTIKA PARICHARYA (POST NATAL CARE)

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
To assess the clinical efficacy of Soubhagya Shunthi Paka and Dasamoolarishta in SutikaParicharya (w.s.r to postnatal care)

研究概览

简要总结

A postnatal period begins immediately after the separation of placenta and extending up to six weeks (this period varies as some Acharyasdescribed up to 45days or up to 6 months after delivery)1, otherwise called as puerperium or puerperal period. The care given during this period is called as SutikaParicharyain Ayurveda. During the time of labour mother undergoes tremendous physical exertion and becomes extremely debilitated physically and mentally; which leads to derangement of Doshasespecially Vatadoshain the mother*.*These pathological changes cause general weakness, pain abdomen, low back pain, loss of appetite, dysfunction of bladder, post-natal psychosis etc. Apart from these, mother also suffers with Dhatukshya. If this stage is unattended by appropriate measures then that will lead to maternal morbidity.

In order to reduce the postpartum maternal morbidity, reforming postpartum care measures by providing holistic and flexible maternal health care is necessary. The WHO suggested that maternal care should be de-medicalized, individualized, family-centered, multidisciplinary, holistic, and culturally appropriated.

In the existing modern medical system, puerperal care limits to supplementation of the iron, calcium and prevention of infections. Two major demands of Puerperium i.e. care for proper involution of genital organs and ensuring optimum lactation are still left un-addressed. Whereas in Ayurveda medicaments and procedures described for post-natal woman is culturally very much appropriate, is by and large comprehensive in serving all the demands of the pueperium. It is by far more scientific and helps in proper involution of the uterus, ensures optimum lactation, kindles digestive as well as metabolic fire, replenishes the lost Dhatu (tissue elements), prevents infections, helps to regain tone of urinary bladder and other smooth muscle

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organs like intestines, finally it ensures the uneventfullpueperium and complete growth of the baby.

ImportanceofThis****Work:

In the modern system of medicine supplementation of heamateanics, Calcium and Vitamins are available

for the management of Sutika Kala (post-natal phase). These medicines will take care of replenishment of

mineral and vitamins only. However the other demands of post-natal phase like strengthen of uterus and

urinary bladder, adequate quantity of breast milk and also improvement appetite as well as general well

being are not full filled with these treatments. These Ayurvedic formulations (SoubhagyaShunthiPaka and

Dashamularista) has been in use since ages, and has been found to be useful in treating Sutika (post-natal

women) and promoting the health. The present study is being undertaken to scientifically study and

validate the effect of this Ayurvedic formulation.

Drug****Review

In the present study two popular and classical prescription of Ayurveda are taken up for validation namely Dashamularishta and SoubhagyaShunthiPaka.

**1.**SoubhagyaShunthiPaka(AFI-I, Vol-I, Page No-160-162)

This formulation is prescribed in Ayurvedic classics in the management of Sutika (Pueperal woman) and is also used by folks in different parts of Indian subcontinent. This formulation is very appropriate in catering the demands of the post natal phase like involution of uterine, achievement of optimum lactation, regaining of tone of urinary bladder, intestines etc. This drug is mentioned in Ayurvedic formulary of India, Volume-I, page number 160-162.

**2.**Dashamularista(AFI-I, vol-I, Page No-13-14; API-part-II, vol-II, Page No20-24)

Dashamularishta is the first line compound drug used in the management of Vata predominant disorders. Sutika phase is predominant of Vata; it gets aggravated during labour and same aggravation continues in the post natal phase also due to Dhatukshaya (tissue destruction and loss). Hence in the present study Dashamularishta is taken up for validation. Some studies are also carried out with this drug in Post natal care. This preparation is standardized and also mentioned in Ayurvedic Formulary of India-I, in volume-I, Page No-13-14; API-part-II, Vol-II, Page No20-24.

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Co-ordinating****Centre:

研究设计

研究类型
Interventional

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Primipara / Multipara with non-complicated full term vaginal delivery,
  • Age between 20 – 35 years
  • Woman willing and able to participate in the study.
  • Woman in 3rdto 10thpostnatal day.

排除标准

  • Woman who delivered by Caesarian section or forceps delivery/ vacuum application
  • Woman after 11thpostnatal day.
  • Puerperium associated with complications like severe postpartum haemorrhage, acute inversion of uterus, puerperal eclampsia, psychosis, postnatal gestational Diabetes
  • With uncontrolled hypertension (>160/100 mm of Hg).
  • With evidence of malignancy.
  • Mothers with active herpes breast/breast abscess/retracted nipple/severely cracked nipples, having h/o of HbsAg+ve, HIV+ve, Tuberculosis, Chronic medical conditions.
  • Any other condition which the Principal Investigator thinks may jeopardize the study.

结局指标

主要结局

To assess the clinical efficacy of Soubhagya Shunthi Paka and Dasamoolarishta in SutikaParicharya (w.s.r to postnatal care)

时间窗: To assess the clinical efficacy of Soubhagya Shunthi Paka and Dashamularista in SutikaParicharya (w.s.r to postnatal care)

次要结局

  • To assess the clinical efficacy of Soubhagya Shunthi Paka and Dashamularista in SutikaParicharya (w.s.r to postnatal care)(Improvement in Quality of life by the sustainable effect of Soubhagya Shunthi Paka and Dashamularista.)

研究者

申办方类型
Government funding agency

研究点 (1)

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