A prospective, assessor blind, open, parallel group study to observe the effects of Basti procedure (medicated enemas) on selected metabolic and immunological markers in patients suffering from Sthoulya (Obesity)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Changes in metabolic and immunological status of the patients
研究概览
简要总结
Obesity, characterized by abnormal or excessive fat accumulation impairing health, is defined by the World Health Organization (WHO) as a Body Mass Index (BMI) equal to or more than 30kg/m2. Ayurveda, the Indian traditional medicine system has described Panchakarma i.e. “five procedures†[including Vamana (induced emesis), Virechana (induced purgation), Anuvasana Basti (medicated enema with oils), Niruha Basti (medicated enema with decoction) and Nasya (nasal instillation of medicines)] as therapeutic modalities. These procedures are widely practiced by Ayurvedic physicians and are extremely popular among patients as an intervention for many disorders especially life-style disorders including obesity where basti is the recommended procedure. The indications and contra-indications for basti therapy as well as the probable mechanism behind the multi-systemic effect of the procedure have been well documented in Ayurveda.
An exhaustive literature search did not reveal any reports on the effects of Panchakarma on patho-physiological alterationsin obesity. Hence, this clinical study was planned to explore whether a course of basti has any effect on the metabolic and immunological status in obese individuals**.** The study did not aim at evaluating efficacy of the intervention. Additionally, since it is difficult to employ an appropriate comparator for a complex therapeutic procedure such as panchakarma, an open label study (without a control group) was carried out where pre-intervention and post-intervention variables were compared.
The recruitment of patients and collection of blood samples was done at RA Podar Medical (Ayu) College and MA Podar Ayurvedic Hospital. The Ethics Committee of that Institute ( RA Podar Medical (Ayu) College and MA Podar Ayurvedic Hospital) oversaw the project. ACTREC did immune functions under the oversight of the same EC
A total of 48 fulfilled eligibility criteria and were recruited in the study. 32 participants completed the study while 16 droped out from the study. The subject was under observation for a total of 138 days after being recruited in the study. The day Sample 1 (S1) was collected was designated as Day 0, S2 was collected on Day 48 (16 basti days and 32 days of life style and diet restrictions) and S3 on Day 138.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of Sthaulya i.e. having classical signs and symptoms of Sthoulya58 like i.
- •Mansmedo ati vridhi will be determined by following criteria.
- •BMI more than 30 b.
- •Waist hip ratio more than 0.
- •Sphik stana udar lumbanam: Pendular movement of breast, thighs, abdomen.
- •Ayathoupchayo utshaah: Inability and non-willingness to carry out the work enthusiastically in spite of physically being capable to do so.
- •Patient is ready to abide by trial procedures and to give informed consent.
排除标准
- •Patient requiring acute medical care.
- •Patient having BMI less than 30 kg/m2
- •Disease related to Annava-Purishavahastrotasas (Ajeerna, Atisara, Aruchi, Chhardi, Pravahika, Amadosha, Mandagni, Arsha, Baddagudodara) and pranavahatrotasas (kasa, Swasa, Hikka).
- •Patient with multi-organ involvement, cardiac, respiratory, hepatic and renal disease.
- •Patients with Peet sneha, Garpeeta, Urusthambha, Galganda, Apachi, Shleepada.
- •Pregnant or lactating women (in women of child bearing age, a urine pregnancy test will be performed to rule out pregnancy).
- •Patient who has experienced panchakarma Vyapad (unwanted effects/ complications previously).
- •Patient who has received any of the Panchakarma procedure in last 2 months.
结局指标
主要结局
Changes in metabolic and immunological status of the patients
时间窗: 0 day, immediately after completion of procedures and 90 days after completion of procedures
次要结局
- Changes in clinical signs and symptoms of Sthaulya (Obesity)(0 day, immediately after completion of procedures and 90 days after completion of procedures)