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临床试验/CTRI/2025/08/093805
CTRI/2025/08/093805尚未招募2 期

Evaluation of Efficacy and Safety of Takmeed e Muhallil (Hot and Dry Fomentation with the Bundle of Specific Drugs) with Habb e Suranjan Orally in the Management of Plantar Fasciitis (Waja al Aqib)

Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年9月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

Takmeed e Muhallil Hot and Dry Fomentation with the Bundle of Specific Drugs with Habb e Suranjan Orally in the Management of Plantar Fasciitis Waja al Aqib is designed to assess the safety and effectiveness of these Unani treatments in patients with plantar fasciitis. The aims are to provide a safe effective and economical treatment for heel pain and to improve the quality of life of patients. The study will be conducted at Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Bhopal over a duration of one year with therapy lasting thirty five days. Plantar fasciitis is a common cause of heel pain disability and poor quality of life particularly in middle aged women obese individuals and young male athletes. In Unani medicine it is described as Waja al Aqib a type of Waja ul Mafasil or joint pain. Traditional remedies such as Takmeed and Habb e Suranjan have been used for pain and inflammation but require scientific validation. This randomized open controlled study will recruit eligible patients after ethical clearance and informed consent. Pre treatment investigations including blood tests arthritis profile X ray and ultrasound of the foot will be done. The test group will receive Takmeed e Muhallil locally along with Habb e Suranjan orally while the control group will receive therapeutic ultrasound. Treatment will be given in multiple sittings over four weeks and patients will be followed up on days 7 14 21 28 and 35. Outcomes will be measured using Visual Analogue Scale Lower Extremity Functional Scale SF 12 quality of life and range of motion by goniometer. The inclusion criteria are patients aged 18 to 60 years with plantar fasciitis with or without calcaneal spur and without surgical indication or malignancy. Exclusion criteria include rheumatoid arthritis osteoporosis systemic arthritis infections vascular or metabolic diseases such as gout pregnancy and recent steroid or NSAID use. The total sample size will be 44 patients with 22 in each group. Temperament or Mizaj will also be assessed according to classical Unani parameters. Concomitant medications will be recorded but painkillers will only be permitted in urgent situations as rescue therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Plantar fasciitis with/without calcaneal spur
  • Patient fulfilling the inclusion criteria and agree to follow the protocol
  • plantar fasciitis without any surgical indication
  • Patients having no malignancy.

排除标准

  • 1.Rheumatoid arthritis 2.Osteoporosis 3.Systemic diseases like inflammatory or degenerative polyarthritis, local or systemic infection, peripheral vascular diseases, metabolic disease, such as gout.
  • 4.Pregnant patients 5.Previous treatment: Corticosteroid injection in the last 6 months or NSAIDs treatment within the last 7 day.
  • 6.Unwillingness or inability to comply the requirement of the protocol.

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: on 0, 7,14,21,28 and 35th day

Lower Extremity Functional Scale (LEFS)

时间窗: on 0, 7,14,21,28 and 35th day

次要结局

  • SF 12 (Quality of life)(Range of motion (Goniometer))

研究者

发起方
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Adeeba Noureen

Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital

研究点 (1)

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