A Comparative clinical study to evaluate the effect of Jyotishmatyadi churna alongwith Satpushpa taila Matra basti in the management of Artavakshaya wsr to Oligo-Hypomenorhhea
试验速览
- 阶段
- 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
- 1- To assess the efficacy of Jyotishmatyadi churna along with satpushpa taila Matra Basti inthe management of Artavakshaya.
研究概览
简要总结
The study is entitled as – “A comparative clinicalstudy to evaluate the effect Jyotishmatyadi churna
alongwith Satpushpataila Matra Basti in the management of Artavakshaya w.s.r.Oligo-Hypomenorrheaâ€.
Objective of study – To compare the efficacy ofJyotishmatyadi churna and Jyotishmatyadi churna
alongwith Satpushpa taila Matra Basti in the management ofArtavakshaya w.s.r. Oligo-Hypomenorrhea.
Type of study – Randomized comparative open clinicaltrial.
Administration of trial therapy – Minimum 40 patienthaving cardinal symptoms of Artavakshaya will
registered into groups.
Group A – Jyotishmatyadi churna ( 3 gm ) twice a daywith milk after meal ( after clearance of menses ).
Group B – Jyotishmatyadi churna ( 3 gm ) twice a daywith milk after milk and Satpushpa taila Matra
Basti ( 60 ml ) once in a day for 9 days ( after clearanceof menses ).
Duration of period – 3 consecutive cycles ( 2 cycleswith trial drug and one cycle drug free follow up ).
Therapy period – 2 consecutive cycles after clearanceof menses.
Follow up during treatment – On the clearance of eachmenstrual cycle during the period of treatment.
Criteria for selection of patient -
Diagnostic criteria – Diagnosis will be based on the presence of anyone or more of the cardinal symptoms of Artavakshaya.
A. Yathochitakala Adarshanam of Artava –Menstrual cycle > 35 days
B. Alpartavam –
1. Duration of bleeding < 2 days
2. Decrease in quantity of Bleeding
**C.**Yoni Vedana
Inclusion criteria –
1. 1 . Patients between age group of 18 – 40 years.
2. 2 . Patients fulfilling the cardinal symptoms ofArtavakshaya.
3. 3 . Patients willing to participate in the studywith proper written consent.
Exclusion criteria –
1. Patient having systemic disease (HTN, TB , DM )
2. Thyroid disorder
3. Pregnant and Lactating women
4. Patient on 0CPs , IUCD
5. Congenital anomalies of uterus or ovaries
6. Patient with any pelvic pathology or malignancy
7. PCOD
8. Hb% less than 10 gm
Investigation – At the time of registration.
1. Hb%
2. ESR
3. FBS
4. LFT
5. Thyroid profile
6. USG – Pelvic region ( Endometrial thickness )
7. UPT
Assessment criteria – Assessment will be done on the basis of improvement in the sign andsymptoms
for the purpose.
Subjective criteria –
1. Interval between two cycles
2. Duration of bleeding
3. Amount of blood loss
4. Pain during menstruation – assess with the helpof VAS scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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- Patients between the age group of 18-40 years.
- •2- patients fulfilling cardinal symptoms of Artavakshaya.
- •3- patients willing to participate in the study with proper written consent.
排除标准
- •1- patient having systemic diseases(HTN,TB,DM) 2- Thyroid disorder 3- Pregnant & lactating women 4- patient onOCPs,IUCD 5- Congenital anomalies of uterus or ovaries 6- Patient with any pelvic pathology or malignancy 7- PCOD 8- Hb% less than 10 gm.
结局指标
主要结局
1- To assess the efficacy of Jyotishmatyadi churna along with satpushpa taila Matra Basti inthe management of Artavakshaya.
时间窗: 3 consecutive cycle (2 cycle with trial drug and one cycle drug free follow up.
2- To assess the efficacy of trial therapy on subjective parameters like interval between two cycle,duration of bleeding,amount of blood loss and pain during menstruation- assess with the help of VAS scale.
时间窗: 3 consecutive cycle (2 cycle with trial drug and one cycle drug free follow up.
次要结局
- To assess the efficacy of trial therapy on subjective parameters like interval between two cycles,duration of bleeding,amount of blood loss and pain during Menstruation- assess with the help of VAS scale.(3 consecutive cycles (2 cycles with trial drug and one cycle drug free follow up ).)
