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临床试验/CTRI/2024/08/072303
CTRI/2024/08/072303尚未招募2/3 期

A Comparative Clinical Study on the effects of Hijama-bila-Shart and TENS in the Management of Usr-e-Tams Ibtedai (Primary Dysmenorrhea)

State Unani Medical College and Hospital Prayagraj1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月14日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

Dysmenorrhea is a common gynecological problem in women of reproductive age. In general, it begins with the first ovulation cycle and occurs about two years after menarche and most of the severe episodes occur before 25 years of age. Dysmenorrhea word is derived from Greek language ‘dys’ meaning ‘difficult’, ‘painful or abnormal’, ‘meno’ meaning ‘month’ and ‘rrhoea’ meaning ‘flow’ that means ’Painful menstrual flow. The affected women experience sharp, intermittent spasm of pain usually concentrated in the suprapubic area but pain may also radiate to the back and along the thighs. It affects more than 50% of menstruating women in age group 18- 25 years. It is estimated that 60% of girls of 12-17 year of age group complaint of dysmenorroea and 50% of women experienced some degree of dysmenorrrhoea, while 10% are incapacitated by it. It has been also estimated in some studies upto 75% of young women will experience some dysmenorhhoea in spontaneous menstrual cycle with 15-20% of women experiencing severe pain.

 In Unani System of Medicine dysmonorhhoea is known as ‘Usr-e-Tams’ but most of the Unani physicians such as Ibn-e-Sina and Abu Bakar Zakaria Razi described the term “dysmenorrhea” under the context of “auja-e-rahem” that is the pain of uterine origin. They had sound knowledge of this condition and mentioned their personal experiences under various topics like ‘Su-e-Mizaj mukhtalif’, ‘ghaleez balghem wa sauda’, ‘reeh’, ‘Ihtebas-e-tams’, ‘warm-e-rahem’. Zakaria Razi in his book ‘Alhavi fit tib’ mentioned that causes of dard-e-rahem are ‘warm-e-rahem’ , ‘ahtebas-e-tams’, ‘seelan-e-khoon’, ‘seelane-e-mani’, ‘dabela’ , ‘insedade fam-e-rahem’ , and ‘ikhtenaqur rahem.In ‘Alqanoon fit tib’ , Ibn e sina said that Usr-e-Tams is caused by different type of su-e-mizaj, amraz-e-rahem sabiqa, Qillat-e-tams, insedade fam-e-rahem, and sartan-e-rahem. Hakeem Azam Khan in his book Kitabul Akseer-e-Azam described lots of cause of dymenorhhoea such as su-e-mizaj or tamaddudi riyah, mugallid-e-riyah, and nafakh-e-rahem etc.

 Unani Physicians worked on the theory of temperament and succeeded in locating the relationship between diseases, variation of humours and disturbance of the temperament. In Unani system of medicine, treatment is based on the understanding that a particular illness in the patient has developed due to disharmony in her temperament, which has deviated from its equilibrium status. Therefore, the objective of treatment is rectification of the disturbance of temperament. According to Unani physicians, it is the altered temperament (Su-e-Mizaj) that causes obstruction in flow of menstruation fluid that results difficult menstruation. Treatment is therefore, aimed directly at restoring balance to patient’s temperament or humours. The conventional medicines prescribed for treatment of dysmenorrhea are NSAIDs and OCPs (prostaglandin inhibitors) that have notable side effects like nausea, stomach irritation, gastrointestinal ulcers and impaired renal blood flow etc. Therefore, Unani drugs formulations, and Regimenal therapies like hijama (cupping), fasd (venesection), dalk (massage) and physical exercises etc. which have least or no side effect on human body, so that many people generally attracted towards the Unani system of medicine.

 Hijama-bila-Shart has great potential to treat Usr-e-Tams according to most of the Unani scholars. In spite of that, Unani system of medicine is a need of the hour to evaluate the significant scientific validation and documentation of Hijama-bila-Shart. The scientific validation of Hijama-bila-Shart in the management of Usr-e-Tams will help to approve by the other countries worldwide in the scientific era. Thus, Hijama-bila-Shart will become more widely accepted and effective treatment of Usr-e-Tams by the society globally.

 TENS (Transcutaneous Electrical Nerve Stimulation), is the application of moderate frequency current in the form of pulsed rectangular currents via surface electrodes on patients skin to reduce pain. It is non invasive conventional intervention to treat pain conditions. Specifically, high frequency TENS, which involves electric puls delivered between 50 and 120 Hz has been found to be more effective in primary dysmenorrhea, it is safe, portable and inexpensive.

The present study has been designed to compare and evaluate the effects of Hijama-bila-Shart with TENS in the management of Usr-e-Tams Ibtedai (Primary Dysmenorhhoea). Therefore, the present study is entitled as “A Comparative Clinical Study on the Effects of Hijama-bila-Shart and TENS in the management of Usr-e-Tams (Primary Dysmenorrhoea)”.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
13.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Having regular menstrual cycle.
  • Lower abdominal pain, with cramp along with nausea, vomiting and backache.
  • Unmarried women.
  • Absence of any pelvic pathology.
  • Patient with oligomenorrhoea and painful menstruation.
  • Obtaining a score higher than four on the pain Visual Analogue Scale.

排除标准

  • Age below 13year or above 30 year.
  • Any systemic illness such as Liver, Cardiac, Pulmonary, Diabetes mellitus and Hypertension, Hypothyroidism etc.
  • History of any skin allergy, epilepsy or convulsions.
  • Patient taking NSAIDs and on Hormonal therapy.
  • Any gynecological disorders like DUB, PID, Ovarian cyst, Uterine fibroid, Irregular menses.
  • History of Recent Surgery.
  • Umbilical hernia or any Incisional hernia.

结局指标

主要结局

Pain intensity

时间窗: Day 0, 1st, 2nd, 3rd menstrual cycle

1.VAS ( Visual Analogue Scale)

时间窗: Day 0, 1st, 2nd, 3rd menstrual cycle

2.VMSs ( Verbal Multidimensional Scoring System)

时间窗: Day 0, 1st, 2nd, 3rd menstrual cycle

次要结局

  • Quality of life(1.MSQ (Menstrual Symptom Questionnaire))

研究者

发起方
State Unani Medical College and Hospital Prayagraj
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Huma Ishrat

State Unani Medical College and Hospital Prayagraj

研究点 (1)

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