Efficacy and Safety of Karafs (Apium graveolens Linn) and Hulba (Trigonella foenum graecum Linn) in the management of Usr-e-Tams Ibtedayee (Primary Dysmenorrhoea):A randomized single blind controlled study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DECREASE IN VAS AND VMSS SCORES FOR PAIN INTENSITY
研究概览
简要总结
DYSMENORRHEA IS A PAINFUL MENSTRUATION OF SUFFICIENT MAGNITUDE SO AS TO INCAPACITATE DAY TODAY ACTIVITY. IT IS PAINFUL AND CRAMPING SENSATION IN THE LOWER ABDOMEN OFTEN ACCOMPANIED BY BIOLOGICAL SYMPTOMS SUCH AS FATIGUE AND DIZZINESS OCCURRING JUST BEFORE OR DURING THE MENSES. THE INCIDENCE OF PRIMARY DYSMENORRHEA OF SUFFICIENT MAGNITUDE WITH INCAPACITATION IS ABOUT 15-20%. IT IS A VERY COMMON COMPLAINT, EXPERIENCED BY 45-95% OF WOMEN OF REPRODUCTIVE AGE GROUP. DYSMENORRHEA IS OF TWO TYPES: PRIMARY DYSMENORRHOEA (USR-E-TAMS IBTEDAYEE) IS A COMMON GYNECOLOGICAL COMPLAIN REFERS TO THE OCCURRENCE OF PAINFUL MENSTRUAL CRAMPS OF UTERINE ORIGIN DURING MENSTRUATION IN THE ABSENCE OF AN IDENTIFIABLE PATHOLOGICAL LESION. PRIMARY DYSMENORRHEA USUALLY APPEARS WITHIN 1-2 YEARS OF MENARCHE, WHEN OVULATORY CYCLES ARE ESTABLISHED. THE DISORDER AFFECTS THE YOUNGER WOMEN BUT MAY PERSIST INTO THE 40S. IT AFFECTS MORE THAN 50% OF POST PUBESCENT WOMEN IN THE AGE GROUPS OF 18-25 YEARS. IT IS COMMON IN ADOLESCENT AND CHARACTERIZED BY SPASMODIC PAIN BEGINNING WITH ONSET OF MENSTRUATION AND LASTING 12-24 HRS. IN CLASSICAL UNANI LITERATURE, USR-E-TAMS HAS BEEN DESCRIBED AS DARD AL-RAHIM OR AUJA’-E- RAHEM. THE PAIN USUALLY OCCURS IN THE UTERUS AND SPREADS TO THE SURROUNDING AREAS. IT HAS BEEN MENTIONED THAT ANY OBSTRUCTION TO THE FLOW OF MENSTRUAL BLOOD ALTERS THE TEMPERAMENT (SU-I-MIZAJ) RESULTING IN DIFFICULT OR PAINFUL MENSTRUATION, SO THE DRUGS PRESCRIBED FOR THE TREATMENT OF USR E TAMS SHOULD BE POSSESSING THE PROPERTIES OF MUHALLIL, MUDIR E HAIZ, MUSAKKIN AWJAH, MUFATTIT SUDAD. THE PRESENT FORMULA OF DECOCTION OF TUKHME KARAFS (APIUM GRAVEOLENS, LINN) AND TUKHME HULBA (TRIGONELLA FOENUM GRAECUM, LINN) TAKEN FOR THE PROSPECTIVE STUDY IS ALREADY MENTIONED FOR THE TREATMENT OF USR E TAMS IN UNANI PHARMACOPOEIAL BOOK AKSEER-E-AZAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •PATIENTS OF AGE GROUP 12-35 YEARS, PATIENTS WITH REGULAR PAINFUL MENSTRUATION MAY BE ASSOCIATED WITH ONE OR MORE SYMPTOMS LIKE NAUSEA VOMITING DIARRHEA FATIGUE, STRICTLY PRIMARY DYSMENORRHEA, PATIENTS WILLING TO TAKE PART IN THE STUDY.
排除标准
- •HORMONAL AND METABOLIC DISORDERS, ANY ORGANIC PELVIC PATHOLOGY, SENSITIVITY TO NSAIDS, ANY SYSTEMIC DISEASES LIKE HYPERTENSION DIABETES MELLITUS, PATIENTS WITH SECONDARY DYSMENORRHEA, LACTATING WOMEN, IF THE PATIENT NOT WILLING TO CONTINUE.
结局指标
主要结局
DECREASE IN VAS AND VMSS SCORES FOR PAIN INTENSITY
时间窗: 3 CONSECUTIVE MENSTRUAL CYCLES
次要结局
- IMPROVEMENT IN THE QUALITY OF LIFE DETERMINED BY SF 36 HEALTH SURVEY QUESTIONNAIRE, REDUCTION IN THE DURATION OF PAIN ASSOCIATED SYSTEMIC SYMPTOMS AND PBAC SCORE FOR MENSTRUAL BLOOD LOSS(3 CONSECUTIVE MENSTRUAL CYCLES)
研究者
SHAMMA PARVEEN
ALIGARH MUSLIM UNIVERSITY ALIGARH
