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临床试验/CTRI/2022/04/041911
CTRI/2022/04/041911尚未招募2 期

COMPARATIVE CLINICAL STUDY OF MENOCRAMP TABLET AND SAPTASARAM GHAN VATI IN THE MANAGEMENT OF KASHTARATVA (PRIMARY DYSMENORRHEA)

Solumiks Herbaceuticals Limited1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年4月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
150
试验地点
1
主要终点
pain relief

研究概览

简要总结

In our society women is compared to mother earth as both have the quality of forbearance and procreation.

Dysmenorrhea is a medical condition of painful menstruation of sufficient magnitude so as to incapacitate day to day activities .

The prevalence rate of dysmenorrhea in adolescent girls is 70.2% in india.

According to Acharaya Sushruta , pain is indication of vata vikruti.

Ø  Majority of previous works carried out were either based on procedure like Uttarbasti or were based on basti. Since it is impossible for uttar basti to be performed on unmarried patients, and also the young those hesitate to undergo Matra Basti who are the most sufferers. Only few works have been done on oral form of medicine for the treatment of Kashtartava.

Ø  Till date, no successful advances have been made in the management of Primary dysmenorrhea by conventional medicine. The best evidence-based treatments are NSAIDs and hormonal contraceptives but they have a lot of side effect.

Ø  According to Ayurveda, pain is an indication of Vata Vikriti. Vitiated Apana Vata is considered as the primary cause for Yoni vikara’s. Hence, all measures capable of suppressing Vata are indicated.

AIM:

The present study has been planned to accomplish following aims and objective:

·       To evaluate and compare the efficacy of “Saptasaram ghan vati†with Menocramp tablets in the management of Kashtartava.

OBJECTIVE**:**

·       To evaluate the effect of drug on associate complaints of dysmenorrhoea.

·       To assess the efficacy of drug in reducing the psychological complaints associated with dysmenorrhoea.

HYPOTHESIS**:**

·       Null Hypothesis (H0): Saptasaram ghan vati is not effective in the management of Kashtartava whencomparedtoMenocramp tablets.

·       Alternate Hypothesis (H1): Saptasaram ghan vati is more effective in the management of Kashtartava whencomparedtoMenocramp tablets.

Diagnostic Criteria:

·       Painful menstruation of acute and spasmodic nature

·       Pain of sufficient magnitude to hamper the routine daily activities for 48 - 72 hours duration in regular menstrual cycles.

·       Associated with or without constipation, loose stools, nausea, breast tenderness, mood swings, headache, giddiness, irritability.

Study Duration:

·       1 menstrual cycle

·       Medicine will be given from first day of menses till 5th day of menses for one cycle

·       Follow up for next one menstrual cycle without medicine for both groups.

Assessment of Pain (Dysmenorrhea):

VISUAL ANALOGUE SCALE

NO PAIN

(0)

ANNOYING (MILD)

(2 TO 3)

UNCOMFORTABLE

(MODERATE) (4 TO 6)

HORRIBLE

(SEVERE) (7 to 9)

WORST (10 )

WaLIDD SCORE VARIABLE

Working ability

Location

Intensity

Days of Pain

|0 None

0 None

0 Does not Hurt

0 Zero

|1 Almost never

1 one site

1 Hurts a little bit

1 One- Two

|2 Almost always

2 two – three sites

2 Hurts a little more- hurts even more

2 Three- Four

|3 Always

3 four sites

3 Hurts a whole lot – hurts worst

3 >Five

Notes: Score 0 without Dysmenorrhea, 1- 4 mild Dysmenorrhea, 5-7 moderate Dysmenorrhea, 8-12 severe Dysmenorrhea.

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
15.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Women between the age group 15 to 30 years.
  • Women with regular cycle with painful menstruation.
  • Women without any pelvic pathology.
  • Be able and willing in the view of the investigator to comply with all study procedures and sign informed written consent form.

排除标准

  • Women with history of PID endometriosis and debilitating pathological conditions of the pelvic organs, systemic diseases like diabetes mellitus bronchial asthma tuberculosis thyroid dysfunction with organic lesion benign or malignant growth of reproductive tract uterine prolapse and Hypo-plastic uterus Women with congenital anomalies of genital organs Polycystic ovarian disease Patients with chronic hepatic neurological or orthopedic conditions neuropsychiatric illness malignancy or AIDS Subjects rejecting to sign the consent form drug addicts Patients with clinically significant cardiovascular, hematological, pancreatic metabolic neurological disorders or clinically significant laboratory abnormalities which in the judgement of the investigator would interfere with the subjects participation in the study or evaluation of the subjects response to therapy.

结局指标

主要结局

pain relief

时间窗: 1 month with 1 month follow up

relief in associated complaints

时间窗: 1 month with 1 month follow up

次要结局

  • psychological relief and improvement in QoL of participants(1 month during study and during follow up period)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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