跳至主要内容
临床试验/CTRI/2022/10/046184
CTRI/2022/10/046184尚未招募2 期

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

State Ayurvedic College and Hospital Lucknow1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月10日最近更新:

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 ).)

研究者

发起方
State Ayurvedic College and Hospital Lucknow
申办方类型
Research institution and hospital

研究点 (1)

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