A comparative clinical evaluation of shatpushpa shatavari churna and shatpushpa taila uttar vasti in the management of artava kshaya with special reference to oligohypomenorrhoea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the efficacy of trial therapy on subjective parameters likeInterval between two cycles,
研究概览
简要总结
Title - A comparative clinical evaluation of Shatpushpa - shatavari churna and Shatpushpa taila uttarbasti in the management of Artavakshaya wsr oligo- hypomenorrhoea.
Objective - To compare the efficacy of Shatpushpa - shatavari churna orally along with Shatpushpa taila uttarbasti in the management of Artavakshaya wsr oligo-hypomenorrhoea.
Type of study – Randomized comparative open clinical trial.
Administration of trial therapy – Minimum 40 patient having cardinal symptoms of Artavakshaya will be registered into two groups.
Group 1– This group of patients will be given the trial drug Shatpushpa- Shatavari Churna 5 gm with ghrita twice a day for 3 consecutive cycles after clearance of menses.
Group 2 – This group of patients will be given the trial drug Shatpushpa- Shatavari Churna 5 gm with ghrita twice a day along with Shatpushpa taila Uttarbasti 5 ml once a day for 3 alternate days for 3 consecutive cycles after clearance of menses.
Duration of trial – 4 consecutive cycles (3 cycles with trial drug and one cycle drug free Follow up).
Follow up during treatment – On the clearance of each menstrual cycle during the period of treatment.
CRITERIA FOR SELECTION OF PATIENT
Diagnostic Criteria-
Diagnosis will be based on the presence of any two or more of the cardinal symptoms of Artavakshaya.
A.Yathochitakala Adarshanam of Artava – Menstrual cycle > 35 days
B.Alpartavam – a) Duration of menstrual bleeding < 2 days
b) Decrease in quantity of menstrual blood (using 1-2 pads per day)
C.Yoni Vedana– Pain during menstruation
Inclusion criteria:
1.Married patients fulfilling the cardinal symptoms of Artavakshaya.
2.Patients between the age group of 20-40 years.
3.Patients willing to participate in the study with proper written consent.
Exclusion criteria:
1.Patient having systemic diseases which interfere with the present study.
2.Pregnant & Lactating women.
3.Patient on OCPs, IUCD.
4.Patient with congenital anomalies of uterus or ovaries.
5.Any other pelvic pathology or malignancy.
6.Anaemic patients (Hb less than 8 gm/dL)
Discontinuation Criteria:
1.Patient does not want to continue trial.
2.Aggravation of complaint
3.Any other acute illness.
Investigation: At the time of registration.
1.CBC
2.ESR
3.RBS
4.LFT
5.Thyroid profile
6.USG uterus and adnexa – TAS/TVS
7.UPT
8.LH , FSH (if needed)
ASSESSMENT CRITERIA
Assessment will be done on the basis of improvement in the sign and symptom for the purpose.
SUBJECTIVE CRITERIA
1.Interval between two cycles.
2.Duration of Menstrual Bleeding.
3.Amount of Menstrual blood loss.
4.Pain during Menstruation.
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
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Married patients fulfilling the cardinal symptoms of Artavakshaya.
- •2.Patients between the age group of 20-40 years.
- •3.Patients willing to participate in the study with proper written consent.
排除标准
- •1.Patient having systemic diseases which interfere with the present study.
- •2.Pregnant & Lactating women.
- •3.Patient on OCPs, IUCD.
- •4.Patient with congenital anomalies of uterus or ovaries.
- •5.Any other pelvic pathology or malignancy.
- •6.Anaemic patients (Hb less than 8 gm/dL).
结局指标
主要结局
To assess the efficacy of trial therapy on subjective parameters likeInterval between two cycles,
时间窗: 2 month
Duration of Menstrual Bleeding,Amount of Menstrual blood loss & Pain during Menstruation.
时间窗: 2 month
次要结局
- To assess the effect of trial therapy in the management of Artavakshaya.