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临床试验/CTRI/2023/09/057542
CTRI/2023/09/057542招募中3 期

Randomised controlled clinical trial of efficacy of Munditika churna and Haritaki churna in the management of Vatarakta (gout)

Pathan Md Junaid Naim Khan1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Improvement in vatarakta sign & symptoms

研究概览

简要总结

Vatrakta is one of the Vatavyadhis, a disease where both Vata and Rakta are afflicted by distinct etiological factors. There are 02 types of Vatarakta i.e., Uttana Vatarakta produces symptoms like itching, burning sensation, pain, brown-blackish discolouration of skin. While, Gambhira Vatarakta produces symptoms like swelling, hardness, tenderness, burning sensation, pain. Sometimes numbness is also present. Vatarakta can be corelated with Gout. Gout is the most common inflammatory arthritis in men and in older women. Gout is the most common form of inflammatory arthritis. As the level of uric acid [in men (≤ 7 mg/dl) and women (≤ 6 mg/dl)] crosses its saturation thresholds in physiological fluids urate crystals precipitation starts in the joints leading to gout. In Ayurveda Vatarakta has been described in detail with different useful treatment modalities. One of such treatment for Vatarakta is classicaly recommended in Bhaishajya ratnavali is Munditika churna & Haritaki churna. so, this RCT is planned to evaluate efficacy of both these churna (Munditika & Haritaki churna). The main outcome of this trial is to evaluate improvement in symptoms viz. 1. Shotha (Swelling)2. Kathinya (Stiffness & Hardness)3. Vedanadhikya (Severe pain)4. Daha (Burning sensation)5. Toda (Pricking pain)6. Shyavata & tamrata (Blackish or Coppery joint discolouration)7. Sphurana (Twitching sensation) and changes in changes in sr. Uric acid levels.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • •Participants having classical sign & symptoms of Vatarakta like.
  • •Shotha (Swelling)
  • •Kathinya (Stiffness & Hardness)
  • •Vedanadhikya (Severe pain)
  • •Daha (Burning sensation)
  • •Toda (Pricking pain)
  • •Shyavata & tamrata (Blackish or Coppery)
  • •Sphurana (Twitching sensation)
  • •Participants having age group between 18 years to 60 years
  • •Participants having Serum Uric acid level > 7 mg/dl in Males & >6 mg/dl in Females
  • •Participants will be selected irrespective Gender, Religion, Socio-Economic status.

排除标准

  • •Participants having complications like Paka, Khanja, Pangulya and Sandhi vakrata will be excluded.
  • •Alcohol and drug abusers, Pregnant and lactating women
  • •Symptomatic participants with clinical evidence of Kidney failure
  • •k/c/o Malignancy, poorly controlled DM, HTN
  • •Participants having other acute or complicated systemic disease which require long term drug treatment.

结局指标

主要结局

Improvement in vatarakta sign & symptoms

时间窗: 15th, 30th, 45th day

次要结局

  • decrease in Hyperuricemia (Sr. Uric acid) level(45th day)

研究者

发起方
Pathan Md Junaid Naim Khan
申办方类型
Other [self]

研究点 (1)

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