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临床试验/CTRI/2024/08/072245
CTRI/2024/08/072245尚未招募Phase 3 4

An Open Label Randomized Controlled Clinical Study to Evaluate the Efficacy of Khadirarishta and Chandraprabha vati as an Adjuvant in Improving Quality of Life of Subjects Udergoing Chemotherapy in Stage 4 Cancer

Dr Mahantagouda S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月19日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Improve The Quality Of Life

研究概览

简要总结

A neoplasm or tumor is defined as a mass of tissue formed as a result of abnormal, excessive, uncoordinated, autonomous and purposeless proliferation of cells, even after removal of growth stimulus which caused

It is the most dreadful, grave and tissue invasive disease which gradually hampers the quality of life, and decreases life expectancy and it is the second leading cause of death worldwide.

The estimated number of incident cases of cancer in India for the year 2022 was found to be 14,61,427 (crude rate:100.4 per 100,000). In India, one in nine people are likely to develop cancer in his/her lifetime. Lung and breast cancers were the leading sites of cancer in males and females, respectively. Among the childhood (0-14 year) cancers, lymphoid leukemia (boys: 29.2% and girls: 24.2%) was the leading site. The incidence of cancer cases is estimated to increase by 12.8 per cent in 2025 as compared to 2020.

By seeing the definition, signs and symptoms of cancer can be corelated with Arbuda and it is defined as swelling occurring in any part of the body due to vitiation of Tridosha, afflicting the Mamsa Dhatu, which is circular, fixed, slightly painful, big or wide spread, deep seated, slowly growing and non-suppurative.

Chemotherapy is the sheet anchor of therapy used in surgical embryonal tumors and as primary treatment in advanced cancers not amenable to surgery or radiation. The care for terminally ill cancer patients includes control of symptoms, control of pain, treatment of psychological disturbances, maintenance of quality of life.

The adverse effects due to chemotherapy remains at highest which includes anorexia, anaemia, nausea, hairloss, constipation, diarrhea, mood changes, easy bruising and infection, maximize their sufferings and deteriorates their quality of life.

It is the need of hour to improve the quality of life of subjects undergoing chemotherapy.

Khadirarishta and Chandraprabha Vati are two Ayurvedic formulations mentioned in Sharangadhara Samhita having direct indications in Arbuda, Gulma, Granthi, Pandu, Aruchi, agnimandya, Balya, Shoola, Pleehodara, Sarvarogahara with Rasayana effect can be administered to improve quality of life in subjects undergoing chemotherapy.

In present study, an effort is put forth to evaluate the efficacy of Khadirarishta and Chandraprabha Vati as an adjuvant in improving quality of life of cancer subjects who are undergoing Chemotherapy in stage 4 cancer.

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 90.00 Year(s)(—)
性别
All

入选标准

  • Subjects above 18 years of age, irrespective of gender, religion, socio- economic status, type and site of the cancer.
  • Who are undergoing chemotherapy in stage 4 cancer.
  • Subjects who are undergone 1or more cycles of chemotherapy.

排除标准

  • Who Are Not Able To Take Oral Medicines 2)Terminally Ill Patients.

结局指标

主要结局

Improve The Quality Of Life

时间窗: Every 15 days for 90 days

次要结局

  • Improvement in Karnofsky scale(Improve in Quality of Life)

研究者

发起方
Dr Mahantagouda S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mahantagouda Shivanna Sasanoor

JSS Ayurveda Medical College and Hospital

研究点 (1)

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