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临床试验/CTRI/2024/10/075849
CTRI/2024/10/075849尚未招募2/3 期

Efficacy of jayanti ashwagandha vatti as adjuvent therapy with antikochs treatment in pulmonary tuberculosis

Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Temperature, Pain, Diarrhoea, Cough, weight gain, Haemoptysis, loss of appetite

研究概览

简要总结

The largest number of cases occurs in the Southeast Asia region which accounts for about a third of the global prevalence and populated nations like China and India are on alarming bomb. Moreover, India is the highest TB burden country accounting for more than one fifth of the global incidence.To prevent acquired resistance and a successful treatment; it is recommended to receive a combination chemotherapy containing the main drugs Isoniazid -H (INH), Rifampicin-R (RMP) and Pyrazinamide-Z (PZA), ethambutol (EMB)and/or Streptomycin. These drugs are used in combination for initial 2 month followed by a continues use of INH + RMP for 4-6 month as a complete treatment regimen for active tuberculosis. To reduce the incidence of hepatotoxicity in TB patients, various measures have been taken with revised recommendations for drugs and patient selection criteria. But until today no drug has been developed in conventional health science for prevention of hepatotoxicity. The only measure available for managing ATT induced hepatotoxicity is withdrawal of the therapeutic drugs when observed an evidence of liver damage and reintroducing the same after normalization of liver enzymes. It has been observed that most of the patients suffering from Tuberculosis find difficulty to complete the recommended treatment regimen due to hepatotoxicity caused due to the ATT drugs. Thus, some adjuvant therapy is essential which could reduce the hepatotoxicity of the therapeutic drugs. Therefore, keeping these facts in mind this study has been planned to provide better, safer and faster relief to thepatients suffering from Tuberculosis and for this I have choose use of Rasayana therapy purpose a compound formulation of Jayanti vati along with Ashwagandha has been prepared. Both of these drugs have well established hepato protective, immuno-modulatory action and are frequently used by Acharyas for the treatment of tuberculosis due to their Rasayana properties.

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

入选标准

  • Patients with sputum positive for pulmonary tuberculosis, sputum negative, chest xray positive, Drug sensitive TB patients.

排除标准

  • extra pulmonary tb, MDR tb, pregnant women and child patients, psychologically disturbed patients, Drug resistance tb patients, patient having hepatotoxicicty, ototoxicity, other complications.

结局指标

主要结局

Temperature, Pain, Diarrhoea, Cough, weight gain, Haemoptysis, loss of appetite

时间窗: 0th, 30th, 60th, 120th, 150th, 180th day

次要结局

  • Sputum for AFB, CXR when required, USG when required(0th, 30th, 60th, 120th, 150th, 180th day)

研究者

发起方
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr pritee omprakashji Varma

Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital

研究点 (1)

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