Pharmacognostical study on Agnimantha with special reference to its role in Sthaulya (Obesity).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1)Reduction in BMI , Body Weight, Waist circumference, Waist - hip ratio .
研究概览
简要总结
Ayurveda defines health as a state of equilibrium of *dosha, dhatu, agni,mala,*and tranquillity of soul, sense organs, and mind and not the mereabsence of disease. The imbalance of dosha, dhatu poshana kriya leads to riskof Sthaulya (Obesity).
In this fast lifestyle, the stress at the workplace and lack of exercisedue to technological advancement has given birth to lifestyle disorders.Obesity is one such grave disorder causing potential harm to humanity. Obesityis defined as the abnormal or excessive fat accumulation in the adipose tissues,to the extent that health may be impaired. This may be either due tohypertrophy or hyperplasia of adipocytes or a combination of both.
In Samhita and Nighnatu, Agnimantha(Premna integrifolia Linn.) has been prescribed for treating Sthaulya(Obesity). It possesses Tikta, katu, kashaya, madhur rasa, Laghu andruksha Guna, Ushna virya, Katu vipaka and is kaphavatshamaka. Itpossesses the property of Kaphamedonivarana. So, the test drug seems tobe rationale for the treatment of Obesity.
Drug Dose:
Agnimanthaghana vati-500mg (2 BD)
Medohara Guggulu -500mg (2 TDS )
Patient’s grouping:
Patientwill be screened according to the inclusion or exclusion criteria and those whowill full fill the inclusion criteria will be randomly allotted (Table method ofrandomization) into two treatment groups.:
A total number of patients will be 70 and they will be divided into two groups i.e. -A, and B. 35 patients will be in each group. The groups with their drugs willbe as follows:
- **Group A: -**Agnimantha Ghana Vati (Trial drug)
- **Group B:**Medohara Guggulu (Control drug)
TRIAL METHODOLOGY
| Group A |
Group B
|Agnimantha Ghana Vati
Medohara Guggulu
|Dosage: 500mg (2 BD)
Dosage: 500mg (2 TDS)
|Trial Group
Control Group
| G**Duration of treatment-**3 months |
In both group, patients were advised mental rest and physical exercise like walking 3 km daily, diet restrictions like avoidance of excess oily, spicy food, and excess sweets.
Follow up – Every 30 days
ROUP A
GROUP B
| | |
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient age group ranging from 18-65 years.
- •Waist Circumference ≥ 102 cm for males and ≥ 88cm for females.
- •Waist: Hip ratio ≥ 0.95 for males and ≥ 0.80 for females.
- •Abnormal lipid profile.
排除标准
- •Patient having BMI>40.00
- •Patient with IDDM and severe hypertension.
- •Patient with severe cardiac and endocrine disease.
- •Patient not giving consent.
- •Obesity due to medicines e.g., Steroids, Contraceptive pills etc.
结局指标
主要结局
1)Reduction in BMI , Body Weight, Waist circumference, Waist - hip ratio .
时间窗: 3 months
2)Improvement in Various components of Lipid profile (S. Cholesterol, S. Triglycerides, HDL, LDL, VLDL).
时间窗: 3 months
3)Improvement in subjective parameters like Gurugatrata (Heaviness in body) , Javoparodha (Inability to do work) , Daurbalya (Weakness) , Daurgandhya (Foul body odour), Ati Kshudha (Excessive hunger), Nidradhikya (Excessive sleep), Ati pipasa (Excessive thirst), Krichavyavayta (Difficulty in performing sexual act)
时间窗: 3 months
次要结局
- 1)Improvement in subjective parameters like Gurugatrata (Heaviness in body) , Javoparodha (Inability to do work) , Daurbalya (Weakness) , Daurgandhya (Foul body odour), Ati Kshudha (Excessive hunger), Nidradhikya (Excessive sleep), Ati pipasa (Excessive thirst), Krichavyavayta (Difficulty in performing sexual act).