COMPARATIVE CLINICAL STUDY ON VATA KAPHAJA ARTAVADUSHTI POLY CYSTIC OVARY SYNDROME AND ITS MANAGEMENT BY LASHUNA CAPSULES AND SHATAPUSHPA TAILA MATRABASTI
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- PIA
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 To compare and evaluate the clinical efficacy of Lashuna Capsule and Shatpushpa Taila Matrabasti on reduction of cyst and decreasing ovarian volume and inducing ovulation
研究概览
简要总结
INTRODUCTION
In Vata-KaphajaaArtavdushti (Granthibhuta), caused by Dushtiof Vata and Shleshma and associated withother features of both the Doshas. WhenArtava Vahini Sira get obstructed by Prakupita Vata and Kapha ,passage of Artavacarrying channel is obstructed. So Artavais not apparent monthly, which results in amenorrhea *(nashtartava)*3 itresults in Nashtaartava. In Artavavahasrotas Viddha Lakshana also ,Artavanasha(Secondary Amenorrhea) is absorbed.5 Therefore the abovesymptoms can be correlated with the symptoms of Poly Cystic Ovary Syndrome(PCOS).
Needof the study-
PCOS is acommon female endocrine disorder with prevalence ranging from 2.2% to 26%. InGlobal ratio, 1 among 15 women have PCOS.Adolescent girls in schools have 9.13%- 36%,Reproductive age- 30% ,Peri-menopausal women - 6-10%.Lashuna which is found to be useful in Pushpa( Artava *)*Rogas8.The indication of Basti in Alpapushpa,Nashtapushpa,Nastabeeja,and Akarmanyabeeja which can be consideredas the symptoms of Artavadushti. 9
HYPOTHESIS:
NullHypothesis (H0):
Lashuna Capsules alone or Lashuna Capsule along with Shatpushpa TailaMatrabasti is not effective in the management of Vata - Kaphaja Artavadushti(PCOS)
Alternate Hypothesis (H1):
Lashuna Capsules alone or Lashuna Capsule along with Shatapushpa TailaMatrabasti is effective in the management of Vata-Kaphaja Artavadushti (PCOS)
RESEARCHQUESTION:-
Is Lashuna Capsule orally alone in a dose of500mg B.D for 2 months in combination with Shatpushpa Taila Matrabasti in adose of 60 ml for 7 days in 2 consecutive menstural cycles is effective inVata-kaphaja Artavadushti (PCOS)INTRODUCTIONIn Vata-KaphajaaArtavdushti (Granthibhuta), caused by Dushtiof Vata and Shleshma and associated withother features of both the Doshas. WhenArtava Vahini Sira get obstructed by Prakupita Vata and Kapha ,passage of Artavacarrying channel is obstructed. So Artavais not apparent monthly, which results in amenorrhea *(nashtartava)*3 itresults in Nashtaartava. In Artavavahasrotas Viddha Lakshana also ,Artavanasha(Secondary Amenorrhea) is absorbed.5 Therefore the abovesymptoms can be correlated with the symptoms of Poly Cystic Ovary Syndrome(PCOS).
Needof the study-
PCOS is acommon female endocrine disorder with prevalence ranging from 2.2% to 26%. InGlobal ratio, 1 among 15 women have PCOS.Adolescent girls in schools have 9.13%- 36%,Reproductive age- 30% ,Peri-menopausal women - 6-10%.Lashuna which is found to be useful in Pushpa( Artava *)*Rogas8.The indication of Basti in Alpapushpa,Nashtapushpa,Nastabeeja,and Akarmanyabeeja which can be consideredas the symptoms of Artavadushti. 9
HYPOTHESIS:
NullHypothesis (H0):
Lashuna Capsules alone or Lashuna Capsule along with Shatpushpa TailaMatrabasti is not effective in the management of Vata - Kaphaja Artavadushti(PCOS)
Alternate Hypothesis (H1):
Lashuna Capsules alone or Lashuna Capsule along with Shatapushpa TailaMatrabasti is effective in the management of Vata-Kaphaja Artavadushti (PCOS)
RESEARCHQUESTION:-
Is Lashuna Capsule orally alone in a dose of500mg B.D for 2 months in combination with Shatpushpa Taila Matrabasti in adose of 60 ml for 7 days in 2 consecutive menstural cycles is effective inVata-kaphaja Artavadushti (PCOS)
Assesmentcriteria-
Subjective–
➢ Menstural History
➢ Duration of Bleeding
➢ IntervalBetween twoMenstrual Cycle
➢ Quantityof Menstrual blood
➢ P****ain During Menstrual Bleeding
OBJECTIVE PARAMETER
➢ Weight
➢ OVULATION (FOLLICULAR SIZE)
➢ HIRSUTISM
➢ ACNE
➢ ACANTHOSIS NIGRICANS ON NECK
ASSESMENT OF……………….
**LABAROTARY INVESTIGATIONS-**1. Hematological examinationslike Hb%, R.B.S.,ESR.
2. U.S.G. Investigation
3. Serum testosterone level.
4. Other investigationif necessary.(URM, FBS,k/c/o –Thyroiddysfunction- T3,T4,TSH,S.Cholestrol)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Women aged as specified above irrespective of marital status 2 Clinical features of PCOS like Oligomenorrhoea Anovulation Anovulatory Infertiliy Acne Hirsutism Obesity Acanthosis nigricans 3 Patient Presenting with VataKaphaja Artavadushti Nastartava Yathochitkaladarshanam Alpamatra Yonivedana Artavanasha 4 Diagnostic criteria Rotterdam revised criteria 2004 2 out of 3 symptoms if present a Oligo and or anovulation b Hyperandrogenism 1 Clinical Acne Hirsutism 2 Biochemical S Testosterone more than 70 ng per m PCOS features on USG more than 12 Follicles of 2 to 9mm in size in each ovary or Ovarian volume more than 10 cc.
排除标准
- •1 Patients having age group Less than 18 yrs and more than 40 yrs 2 Patients having menorrhagia or metrorrhagia 3 Patients with any other Systemic illness like Patients suffering from uncontrolled hypertension Hepatic or Renal disease Cushings syndrome Cardiac diseases diabetes mellitus tuberculosis psychological disorders 4 Organic lesions of reproductive tract like Carcinoma and congenital deformities.
结局指标
主要结局
1 To compare and evaluate the clinical efficacy of Lashuna Capsule and Shatpushpa Taila Matrabasti on reduction of cyst and decreasing ovarian volume and inducing ovulation
时间窗: 60 days | Follow up after 30 days
2 To compare and evaluate the clinical efficacy of Lashuna Capsule and Shatpushpa Taila Matrabasti in regularization of menstrual cycle
时间窗: 60 days | Follow up after 30 days
次要结局
- 1 To review the literature in Vata Kaphaj Artavadushti with special reference to PCOS and review the literature in Lashuna Capsule and Shatapushpa Taila Matrabasti and its therapeutic evaluation in the management of Artavadushti PCOS