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临床试验/CTRI/2024/08/072804
CTRI/2024/08/072804尚未招募1/2 期

EFFECT OF LASHUNA CHURNA AND SHATAPUSHPA GHANA VATI IN PCOS - AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY

Dr Anjum Maheboobpasha Mujawar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Regularity of cycle and reduction in acne

研究概览

简要总结

Polycystic ovarian syndrome is the common health hazard amongst women of reproductive age. It is characterized by oligo-ovulation or anovulation, features of androgen excess and ultrasound appearance of polycystic ovary. The prevalence of PCOS, a common female endocrine condition has been found to range from 2.2% to 26% globally and from 3.7% to 22.5% in India, depends on the diagnostic criteria utilized. PCOS affects 30-40% of women with amenorrhea where as it affects 85-90% women with oligomenorrhea. PCOS affects more than 80% of women who report with signs of androgen excess.

PCOS is associated with weight gain, acne, hirsutism and impaired fertility due to chronic oligo-anovulation. In addition to androgen excess, insulin resistance is a central feature and women with PCOS have shown to be at increased risk of type 2 Diabetes, Hypertension and fatty liver disease. There are no curative options currentlyfor PCOS, therefore treatment aims to alleviate symptoms and prevent long-term complications, including cardiovascular events and endometrial cancer.

The treatment available in contemporary science  like Hormonal therapy, OC pills, Insulin therapy,  prolonged usage end up with other metabolic disturbances, weight gain, acne, skin discolouration (acanthosis nigricans) and serious complications like Pulmonary thrombosis, Genital carcinoma, renal failure.

In Ayurvedic classics there areno direct references of this disease rather, symptoms are found under various diseased conditions at various references, like menstrual irregularitiesdescribed under the Ashtaartavadushti ,Pushpaghni, Jataharini mentioned in Kashyapa Samhita. RevatiKalpa Adyaya10bears similar features of hyperandrogenism like Vruthapushpa(anovulation), Sthoola(obesity), Lomaganda(hirsutism). Sushrutha Samhita gives the referencein ShukrashonitashuddhiAdhyayaabout Nasthartava ( amenorrhea) due to aggravated Kapha, VattaDosha. In DoshadhatumalakshayavridhiAdhyaya there is reference about ArtavakshayaLakshanaslike YathochitakalaAdarshanamAlpadarshana(scanty flow). In Charak Samhita many scattered references are available in different chapters. In  GarbhavakrantiShareera, there is mention of Beejadushti which is characterised by Nashtartava(secondary amennorhea) and SantarpanaotthaVikarain the context of Sthoulya has been described. In AshtangaSangrahaPutarakameeeyaadhyaya there is description of Anartava. Bhavaprakash under NanatmajaVyadhi Nashtartava has been explained. It may understood on the basis of Doshadushtiinvolvement of Dushya, Shrotas, Ama, Agani, AdhishthanaandVyadhiLaxanas.  Metabolic process is correlated with Dhatuagnivikara. Therefore the drug selected for this study is Lashuna and Shatapushpa has been mentioned in Kashyapa Samhita. Both the drugs possess Katu Rasa, UsnaVirya, LaghuTikshnaGuna, KatuVipakaand Vatakapha  Hara, which acts as Artavapravartaka, Yonishodhana, Pradara, Vrushya, Garbhajanaka, Deepana, Pachana  Karma.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Subjects with signs and symptoms of PCOS.
  • Subjects aged between 18- 40 years.

排除标准

  • Subjects already on another drug treatment for PCOS like (OC Pills) 2) Subjects with other functional and structural pathology of reproductive organs.
  • Subjects with known cases of systemic disorders like renal disorders, and metabolic disorders like thyroid dysfunction and gastritis.

结局指标

主要结局

Regularity of cycle and reduction in acne

时间窗: 5 months

次要结局

  • Reduction in hirsutism and Acanthosis nigricans(5 months)

研究者

发起方
Dr Anjum Maheboobpasha Mujawar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anjum Maheboobpasha Mujawar

JSS Ayurveda Medical College and Hospital

研究点 (1)

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