跳至主要内容
临床试验/CTRI/2024/07/070997
CTRI/2024/07/070997尚未招募2 期

A comparative clinical study to evaluate the efficacy of Panchakola Yavagu Vaishwanara Churna Basti followed by Nirgundi Ghana Vati and Panchakola Yavagu Vaishwanara Churna Basti followed by Simhanada Guggulu in Amavata visà vis Rheumatoid Arthritis

NIKITA RATHEE1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月15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
40
试验地点
1
主要终点
To see the effect of both the drugs in reducing the symptoms of Amavata and any changes in investigations if present

研究概览

简要总结

Rheumatoid Arthritis is one of the very common ailments in every age group and Indian as well as western population in recent period. Physical limitations in work, pain, fatigue which in turn affects the mental health are some issues relating to it. Many clinical drug trials and researches have been carried out, yet the management of this disease is insufficient in other system of medicine. So due to much prevalence in society and lack of effective treatment, the disease is being chosen for the study.

Rheumatoid Arthritis is a chronic disease of unknown cause, characterized by persistent inflammatory synovitis, usually involving peripheral joints symmetrically. Common symptoms of Rheumatoid Arthritis include morning stiffness of the joints for more than 30 minutes, fatigue, fever, weight loss, and rheumatoid nodule in chronic phase.

Rheumatoid Arthritis has been common and distressing among all joint problems in recent days. RA is affecting 0.5-1% of population worldwide which is increasing with the increasing population. It is more common in females than in males, female to male ratio is 3:1.

In India, the prevalence of rheumatoid arthritis is 0.75 percent. The onset of disease is frequent between 30-50 years of age with 80% of patients developing the disease between 35-50 years of age.

In contemporary science glucocorticoids, DMARDS, NSAIDS and immunosuppressive treatments are used to treat Rheumatoid Arthritis which are effective in the preliminary stage but in long run may lead to many side effects.

In Ayurveda this disease is compared with Amavata. Ama and vata arevitiated simultaneously and manifestation of disease occurs mainly in joints of hasta, trika, pada, sira, gulpha, uru and janu. The main symptoms seen are Angamarda Aruchi, Trishna, Alasya, Shotha, Gouravam and Apaka.

The disease involves Tridosha though Ama and Vata are the initiating factors in the pathogenesis. Acharya Chakrapanidutta has explained the principles in the treatment of Amavata. These are Langhana (fasting), Swedana (sudation), use of Tikta (bitter) and Katu (pungent) Rasa, Deepana (stimulating hunger), Virechana (purgation therapy) and Anuvasana basti (enema).

Modern science lacks proper treatment. Hence it is our duty being a holistic system of medicine to provide effective, as well as cost effective treatment with less adverse effects*.*

Panchakola siddha yavagu is said to have deepana ,pachana and shulaghana properties.This preparation is taken for deepana and amapachana and relieve the symptoms of patient initially.

Basti is considered as the best in pacifying Vata Vyadhi, so basti by virtue of its versatility and impact is called Ardha Chikitsa. So, it’s a effort to check the effect of Shodhan Chikitsa and Shamana Chikitsa in treatment of Amavata which is thought to do correction of metabolism along with providing symptomatic relief.

Vaishwanara Churna Niruha Basti main ingredients are saindhava , sneha, churna kalka, ushnajala and dhanyamla. Churna consists of saindhava lavana, yavani, ajamoda, haritaki which are having vata kaphahara, deepaniya, shothahara and amahara properties. All these drugs perform Amapachana at Dhatu level, relieves agnimandya. Thus the Samprapti vighatana of the Roga is initiated.

Simhanada Guggulu is Kapha-vatahara, Pittavardhaka, Agnideepaka and Amapachaka. The contents of Simhanada Guggulu have analgesic and anti-inflammatory properties and it is believed to modify the immune response to autoantigens.

Nirgundi has Amavatahara property as said in Bhavaprakasha, considering this Nirgundi Patra Ghana vati is selected as Shamana Aushaudha. Tikta and Katu Rasa present in Nirgundi possesses the antagonistic properties to that of Ama and Kapha which are the chief causative factors in this disease. Due to Agnivardhaka property, this has potential to increase digestive power which also digests Ama and reduces excessive production of Kapha. Being Tikshna and Ushna it also helps alleviate vitiated Vata and reduces Srotorodha and pain. Hence, Nirgundi helps controls Ama and Vata and also minimize the process of pathogenesis of amavata.

Many studies are done on Nirgundi Ghana Vati and Simhanada Guggulu separately and both are found to be effective in Amavata. Hence, keeping Simhanada Guggulu as standard drug, this study aims at comparing both these formulations for the efficacy in Amavata along with effect of Panchakola Yavagu and Vaishwanara Churna Basti common in both groups.

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

  • 1.Patients with lakshanas of Amavata 2.Patients of either gender within age group of 18 years to 60 years 3.Patients with Amavata who are fit for Basti Karma.

排除标准

  • 1.Chronicity of more than 5 years 2.Patients of Amavata having any deformity 3.Patients diagnosed with other systemic disorders interfering with the course of treatment 4.Pregnant & lactating women diagnosed with Amavata.

结局指标

主要结局

To see the effect of both the drugs in reducing the symptoms of Amavata and any changes in investigations if present

时间窗: 1.Before treatment baselinen | 2.8th day - after panchakola yavagu | 3.16th day - After Basti | 4.After 30 days - After oral medicines

次要结局

未报告次要终点

研究者

发起方
NIKITA RATHEE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

NIKITA RATHEE

Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Center

研究点 (1)

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