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临床试验/CTRI/2024/05/066969
CTRI/2024/05/066969已完成2/3 期

A Randomized Clinical Trial To Evaluate The Efficacy Of Mahanarayana Taila Uttar Basti And Punarnavadi Kashaya Yoga Basti In The Management Of Vatastheela With Special Reference To Benign Prostatic Hyperplasia

Parul Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Reduce symptoms of Incomplete evacuation of urine, Increased Frequency Of Micturition, Intermittency, Straining, Nocturia.

研究概览

简要总结

INTRODUCTION  BPH (Benign Prostatic Hyperplasia) is having the 2nd highest incident in geriatrics practice.  The Prostate gets enlarged when a men cross age of 40 years.  One in four men above 40 years and one in three men above 60 years have BPH. However, the chances are even more as men grows older, hence 80% of men above 80 years have chances of BPH.  When Prostate gets larger it generates pressure on urethra because of which the urethra narrow down .  In Ayurveda this pathology has been considered with its clinically simulate ‘’VATASTHEELA”, A diseases which occurs in between the Gudsthana and basti just like a granthi (which is unnat ,achala and hard like ashthi). This granthi formation initiates the avarodh in normal pravritti of vishtha , mutra, apan vayu and ultimately causes of pain and other clinical pathologies in Basti Pradesh.

REVIEW OF LITERATURE

शकृ न्मार्गस्यबस्तेश्च वायुरन्तरमाश्रितः |अष्ठीलावद्धनंग्रन्थंकरोत्यचलमुन्नतम्||७|| श्रवण्मूत्राश्रनलसङ्गश्च तत्राध्मानं च जायते|वेदना च परा बस्तौ वाताष्ठीलेश्रत तांश्रवदुः ||८||SU.U.58

DRUG REVIEW Punarnavadi Kashaya  Sarangdhara madhyama khanda 76-77/2 पाण्डुशोथादौ पुनननवाददक्वाथः पुनननवाऽभयादनम्बदावीदिक्तापटोलक  ७८ गुडू चीनागरयुि  क्वाथो गोमूत्रसंयुिः पाण्डुकासोदरश्वासशूलसवानङ्गशोथहा ७९

ANUVASANA BASTI Taila Quantity Varunadhi Ghrita 30 ml Dashamoola Taila 42 ml

NIRUHA BASTI Madhu 50 ml Lavana 10 gm Sneha Dashamoola Taila  30ml Gomutra 50ml Kalka Total 35gm Satpushpa 10 gm Punarnava 10 gm Gokshur  10gm Yava Kshara  5gm Kwatha Punarnava Kashaya and Ashmarihara Kashaya  200 ml

PREVIOUS WORK DONE  Vd.Sarveshkumar Role of Uttarbasti in the management of BPH; BHU, 2001  Vd.N.H. Kulkarni A clinical study on the role of devdarvyadi kashaya and dashmoolasiddha taila Uttar basti in the management of Mootraghata w.s.r. to BPH;Jamnagar,2002  Randomised controlled clinical trial of Narayan taila Uttatbasti in Vatastheela with special reference to benign prostatic hyperplasia;MUHS,2016  Dr.Shailesh jaiswal  A clinical case study on Dhanyak Gokshura Ghrita Yavakshar Uttar basti in the management of Mutraghata w.s.r. to BPH,2021

AIM  To compare the efficacy of Mahanarayana taila Uttarbasti and Punarnavadi Kashaya Yoga Basti in the management of “Vatastheela” with special reference to Benign Prostatic Hyperplasia (BPH).

OBJECTIVES  To observe the symptomatic relief in Vatastheela using Mahanarayana Taila as Uttar Basti and Punarnavadi Kashaya as Yoga Basti together.  To observe the symptomatic relief in Vatastheela using only Punarnavadi Kashaya as Yoga Basti only.

METHOD OF COLLECTION OF DATA  Sample size: 40 patients.  Study Design: Open Randomised Intervention Study.  Study Period: 28 days

Treatment Duration: 8 days.  20 patients allocated to each group, evenly dividing the participants into two groups

STUDY DURATION  Study time of 8 Days  Follow up period time  28 Days on 7th,14th,21st,28th day

INVESTIGATIONS  Hematological  CBC,  Serum Creatinine ,  Blood Urea , Serum PSA  Urological  Urine Routine & Microscopic  Radiological  Ultra sonography Of Pelvis Uroflowmetry

RESCUE MEDICINE  Antibiotics , Alkalizer

ETHICAL CLEARANCE  It will be obtained from the institutional ethical committee of Parul university  Study will be registered in clinical trial registry of India (CTRI).

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
40.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • Patients having the sign and symptoms of Vatastheela (BPH) Incomplete evacuation of urine Increased Frequency Of Micturition Intermittency Straining Nocturia.

排除标准

  • CA of prostate Bladder neck stenosis Neuropathic disorders of bladder Prostate more than 60 gm and excessive post voidal urine Active UTI Haematuria secondary to renal & bladder stone, cystic kidney disease, Sickle cell anaemia Anaemic patient with Hb below 6 gm%.

结局指标

主要结局

Reduce symptoms of Incomplete evacuation of urine, Increased Frequency Of Micturition, Intermittency, Straining, Nocturia.

时间窗: 28 Days

次要结局

  • Patient health improve.(28 Days)

研究者

发起方
Parul Institute of Ayurved
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kashyap Patel

Parul Institute Of Ayurved

研究点 (1)

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