A COMPARATIVE STUDY OF SHALLAKI (BOSWELLIA SERRATA ROXB.) TWAK AND NIRYAS W.S.R. TO RAKTAPRADAR.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvment in subjective parameter of menorrhagia as-
研究概览
简要总结
Aim of the study is to provide a simple, safe and herbal drug for patient of Raktapradar and Evaluation of efficacy of Shallaki niryas (Kunduru) and Shallaki twak kwath.
Participants fulfilling the inclusion criteria will be selected. Those patients will be selected, who fulfils the criteria of selection and attended the OPD of department of Prasuti tantra and strirog at Pt. Khushilal Sharma Govt. (Auto.) Ayurveda College and Institute Bhopal. The clinical trial will be taken out on 60 (30 Participants in each group) and they were randomly selected and divided into 2 groups:
Group A- Study group
Group B- Study group
CRITERIA FOR DIAGNOSIS
-
Patient presenting with complains of excessive and irregular menstrual bleeding was selected.
-
Including symptoms: Angamarda, vedana, dourbalya, bhrama, murcha, tama, daha, pralap, panduta, tandra, vataj rog.
Assessment criteria: Subjective parameters will be scored as mentioned in specially designed scale and will be compared before and after treatment.
Objective parameter will also be compared at the same interval.
The assessment criteria for Raktapradar will be mainly based on:
[a] Subjective criteria:
-
Bleeding amount in no. of pads
-
Duration of flow or menstrual period (In no. of days)
-
Interval of Menstruation (in no. of days)
-
Pallor (Panduta) (Hb %)
-
Pain (Pain in abdomen / backache)
-
Weakness (Daurabalya)
-
Burning Sensation (Daha)
[b]. Objective criteria: Haemoglobin Level (Hb% Level)
Investigation: Blood: Hb%, TLC, DLC, ESR, CT, BT
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
- 15.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age between Menarche and Menopause
- •Excessive bleeding during menstruation (change of more than 3 soiled pads/day)
- •Passing of large clots.
- •Prolonged Menstrual bleeding (more than 7 days)
- •Excessive bleeding for more than 2 consecutive cycles
- •Intermenstrual Bleeding.
排除标准
- •Intrauterine growth such as Myomas, endometrial polyp etc.
- •Cancer of cervix and or uterus.
- •Hb less than 6 gm %.
- •Any other systemic disorders likely to influence menstrual cycle.
- •Case undergoing treatment for any other serious illness.
- •Woman using an IUCD/ OCP/depot.
- •Venereal disease.
- •Systemic cause mentioned below will also be kept under exclusion criteria: Severe hypertension,Liver dysfunction,Congestive cardiac failure,Patient having bulky uterus, Patients having bleeding from sites other than uterus,Patients having coagulation disorder.
结局指标
主要结局
Improvment in subjective parameter of menorrhagia as-
时间窗: 4 weeks
1. Bleeding amount in no. of pads
时间窗: 4 weeks
5. Pain (Pain in abdomen / backache)
时间窗: 4 weeks
2. Duration of flow or menstrual period (In no. of days)
时间窗: 4 weeks
3. Interval of Menstruation (in no. of days)
时间窗: 4 weeks
4. Pallor (Panduta) (Hb %)
时间窗: 4 weeks
6. Weakness (Daurabalya)
时间窗: 4 weeks
7. Burning Sensation (Daha)
时间窗: 4 weeks
次要结局
- Investigation:(Blood: Hb%, TLC, DLC, ESR, CT, BT)
研究者
Dr Pragya Mandloi
Pt. Khushilal Sharma Ayu. College Bhopal M.P.