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临床试验/CTRI/2025/02/080722
CTRI/2025/02/080722尚未招募不适用

A RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF VASADI KWATH AND AMRUTADI KWATH IN THE MANAGEMENT OF VATARAKTA W.S.R. TO GOUT

Dr. VJD Gramin Ayurved Mahavidyala1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1)Shool (Joints of hands and feet, Parva sandhi, etc.)

研究概览

简要总结

Vatarakta is chronic joint and body pain disease accompanied by pain, stiffness, swelling over joints which involves vitiated Vata dosha as well as *Rakta dhatu.*Aggrevated Vata is blocked by vitiated Rakta which leads to further aggrevation of Vata dosha.

The classical symptoms of Vatarakta are Kandu, Shool, Stambha, Daha, Shoth, Twakkrushnata. The etiological factors responsible for pathology and clinical features of Gouty Arthritis are quite similar to the Vatarakta; hence Vatarakta can be correlated to Gout. Vatarakta manifest hands, feet fingers and all joints. Initially, hands and feet are affected and later it spread to all over the body. Due to subtleness and prevasiness of Vata and liquidity and dispersibility of Rakta, it circulates all over the body through blood vessels, get obstructed in the joints which makes them further aggrevated and get logged there.

The changes of Vatarakta is expected to increase in the upcoming years due to sedentary lifestyle, increasesd use of computerization and also due to mental stress, excess travelling.

It is heterogenous disorder that results in the deposition of Uric acid salt and crystals in and around the joints. Its causes include over production of Uric acid seen in only 10-15% of subjects and in 80-90% Uric acid excretion is impaired.The incidence of gout increases with increasing serum urate level.

It is a fact that despite recent progress of modern science. It is unable to provide an effective cure for Vatarakta except for giving temporary relief through analgesics or continuous use of NSAIDs and steroids for reliving pain lead to secondary complications lie kidney failure, liver failure and gastritis.

The incidence of gout increases with increasing serum urate level. The highest incidence of gout occurs between 30 to 45 yrs in men and 55 -70 yrs in women. It is rare in children and in premenopausal women partly due to mild uricosuric effect of estrogenic hormone. The Maharashtra shows prevalence of gout is 2% .

              In modern treatment no specific therapy is available. The aim is to control pain and maintain maximal degree of joint mobility. The varieties of drug in the medical management is NSAIDs/ Colchicine / Glucocorticoid which fail to modify course of disease or unable to treat the disease and frequently meet with the ill effects of these drugs.The main motto of study is to provide an Ayurvedic treatment modality with minimal side effects as compared to modern treatment

In Ayurveda a detailed description of Vatarakta chikitsa is discussed in all texts along with line of treatment, being Shodhana, Shaman and

Bahyachikitsa. Many therapeutic modalities and different preparation arementioned by our ancient acharyas for Shamana, Shodhana and the Bahyachikitsa, which can effectively treat the disease and it is the need of hour to manage such a condition. Hence this topic is selected for study.

Keeping these facts in mind this study has been under taken to bring out a treatment modality with no side effects and long lasting life. In this study the role of Vasadi kwatha which is simple and potent kalpa described in Bhaishajya Ratnavali with specified indication only in Vatarakta

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients showing classical signs and symptoms of Vatarakta as described in Ayurvedic Samhita.
  • 2.Unilateral first MTP joint attack.
  • 3.Sr Uric acid level ranges between 7 to 12 mg/dl 4.Patients between the age of 20 to 60 years.
  • 5.Patients from all socio-economic status.
  • 6.Either gender.

排除标准

  • 1.Patients not willing.
  • 2.Patients with peptic ulcer.
  • 3.Pregnant and lactating women.
  • 4.Patients who have not been affected by NSAIDs. 5.Patients who have past history of malignant tumour.
  • 6.Sr. Uric acid level below 7 mg/dl and above 12 mg/dl.
  • 7.Patients with Sr. Creatinine level more than 2 mg/dl.
  • 8.Patients below 20 years of age and above 60 yers of age.
  • 9.Patients having any major chronic or acute systemic or surgical pathology.

结局指标

主要结局

1)Shool (Joints of hands and feet, Parva sandhi, etc.)

时间窗: 15Days, 30 Days, 45 Days after starting treatment

2)Stambha (Stiffness)

时间窗: 15Days, 30 Days, 45 Days after starting treatment

3)Daha (Burning Sensation)

时间窗: 15Days, 30 Days, 45 Days after starting treatment

4)Kandu (Itching)

时间窗: 15Days, 30 Days, 45 Days after starting treatment

5)Shoth (Swelling)

时间窗: 15Days, 30 Days, 45 Days after starting treatment

6)Twakkrushnata (Discoloration)

时间窗: 15Days, 30 Days, 45 Days after starting treatment

次要结局

  • Decrease symptoms completely(18 Months)

研究者

发起方
Dr. VJD Gramin Ayurved Mahavidyala
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Gitanjali Shashikant Deshmukh

DR VJD Gramin Ayurved Mahavidyalay

研究点 (1)

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