跳至主要内容
临床试验/CTRI/2021/04/032944
CTRI/2021/04/032944尚未招募不适用

A Randomized controlled clinical trial to evaluate the efficacy between Aatarushadi Kwath Ghana Vati and Kaishore Guggul in the management of Vatarakta.

PDEAS College of Ayurved and Research Center Pradhikaran Nigdi Pune1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年4月26日

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To evaluate the efficacy of Aatarushadi Kwath Ghan Vati 500mg two times a day after meal with lukewarm water and Kaishore Guggul 500mg two times a day after meal with lukewarm water in the management of Vatarakta (Gout) with reference to increase Serum uric acid level within 45 days

研究概览

简要总结

Ayurveda is the science of life. It believes that health and wellbeing

depends on a balance between the three Doshas - Vata, Pitta, and Kapha

which are the physiologic basis of human body, when there is imbalance in

these three doshas than these causes illness.

Vatarakta is one such disease. It was first described as an independent

disease in Charak Samhita. It is a disease of Madhyam Roga Marga as it

affects mainly Sandhis.

In Ayurveda, Vatarakta is said to be caused by adhyashana, virudhasana

(which can be correlated with faulty and irregular dietary habits), krodh

(mental stress), divaswapna and prajagarana (irregular sleep habits),

misthansukhbhojinam, achankramanshila (sedentary life style) etc.

due

to these Nidanas Vata and Rakta gets vitiated. Aggravated Vata is blocked

by vitiated Rakta which in turn leads to further aggravation of Vata. This

aggravated Vata again causes vitiation of whole Rakta. these vitiated Vata

along with deranged Rakta circulates very fast all over the body due to the

Sukshma (Minuteness) and Drava (Liquid state) Guna (characters) of Vata

and Rakta respectively and undergo Dosha-Dushya Sammurchana

(Pathogenesis) in Sandhi sthana (Joints), specifically Kar, Pada and Angula

sandhi (Metacarpo and Metatarso-phalangeal joint).

The characteristics of Vatarakta resemble with those of Gout therefore it

can better be correlated with Gouty arthritis in modern medical science.

Gout is the disease of middle aged group in which an abnormality of Uric

acid metabolism that causes Hyperuricemia and deposition of Mono-

sodium urate crystal in joints causes Acute Gouty Arthritis, in soft tissue

causing tophi and tenosynovitis, in renal tubules causing urate stones and

urate nephropathy.

The general prevalence of gout is 1–4% of the general population. It occurs

in men 2–6 folds more than women. Worldwide incidence of gout

increases gradually due to poor dietary habits such as fast foods, lack of

exercises, increased incidence of obesity and metabolic syndrome.

Conventional drugs used in the management of gout like NSAIDS,

glucocorticoids, xanthine oxidase inhibitors and uricosuric drugs; have

potential side effects and a possibility of drug interaction with other

prescribed drug which restricts their use; because in modern medical

science, its management aspect still remains symptomatic with

troublesome side effects.

With these recurrence and short term benefits in modern system ofmedicine, Ayurveda can provide a very good holistic treatment option.

Today there is need to find the drug which gives long term relief without

any side effects, is easily available, no recurrence and easy to follow.

Bhaishajya Ratnawali has described the efficacy of Aatarushadi Kwath in

management of Vatarakta.

Aatarushadi kwath includes Aatarush (Vasa), Amrita (Guduchi), Erand ,

Avalguja (Bakuchi), Haritaki. Aatarush act as blood purifier.

Amrita act as

tridoshshamak , rasayan , vedna sthapan. Erand has property of

kapha-vata shamak, shoth har, used in rakta vikar. Avalguja has balya

effect on nervous system, shoth nashak and promotes rakta samvahan.

Haritaki has property of rasayan, shonit sthapan, mutral & shoth har.

These five drugs show antagonistic action on prakupit Vata doshas and

Rakta dhatu involved in Vatarakta.

In previous study Kaishore Guggul was found to be significant in the

management of Vatarakta therefore for the present study Kaishore

Guggul will be taken as a control group.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients having clinical signs and symptoms of Vatrakta such as Sandhi shula/Toda (Pain), Sandhi Shotha (swelling), Sparshaashatva (Tenderness), Chimichimayan (tingling sensation),team vaivarnya (Discoloration Of skin).
  • Age group having 20 to 65 years irrespective of religion, gender, socioeconomic status.
  • Patient having serum uric acid more than 7 mg/dl in male and more than 6mg/dl in female.

排除标准

  • Known case of Amavata, Sandhigata vata, SLE, Renal Disease Known case of tuberculosis of any system Chronic joint deformity Hypersensitive reaction to any drug Pregnancy Patients with chronic major illness High risk (above 65 yrs age,known cases of HTN,DM,COPD),Comorbid patients Suspected for Covid-
  • Suspected Covid-19 patients having symptoms as per ICMR guidelines.

结局指标

主要结局

To evaluate the efficacy of Aatarushadi Kwath Ghan Vati 500mg two times a day after meal with lukewarm water and Kaishore Guggul 500mg two times a day after meal with lukewarm water in the management of Vatarakta (Gout) with reference to increase Serum uric acid level within 45 days

时间窗: 45 days with follow up on 15th , 30th , 45th day

次要结局

  • 1. To compare and study the efficacy of Aatarushadi Kwath Ghan Vati(2. To compare and study the efficacy of Kaishore Guggul)

研究者

发起方
PDEAS College of Ayurved and Research Center Pradhikaran Nigdi Pune
申办方类型
Private medical college

研究点 (1)

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