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临床试验/CTRI/2017/05/008497
CTRI/2017/05/008497已完成1 期

A COMPARATIVE CLINICO-EXPERIMENTAL STUDY TO EVALUATE EFFICACY OF VIRECHANA AND KAALA BASTI ALONG WITH SHAMANA THERAPY IN THE MANAGEMENT OF PAKSHAGHATA

IPGT RA GAU JAMNAGAR GUJARAT1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月2日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
to improve the disability produced by pakshaghata

研究概览

简要总结

After careful review of the results obtained during thestudy, following conclusions can be drawn with respect to Pakshaghata and its clinical management, Pharmacological andAyurgenomics study:

Ø  Peakincidence of the disease was after fifth decade establishing the degenerativeaspect of Pakshaghata.

Ø  Physicaland mental stress was the most common causative factor noticed. Disturbedbiological clock associated with professions like security guards, drivers,farmers and fishermen were found to be more prone for development of Pakshaghata. Most of the patientsaffected by the disease were of Vata-paittika prakriti. Addiction of tobacco (chewing and smoking) was aprominent finding in most of the patients.

Ø  Maximumpatients registered had a history of infarct while hemorrhagic cases werelesser in number. Most common presenting complain was weakness of the motorsystem involving upper and lower limbs followed by impaired speech and facialweakness. Minimal sensory involvement was seen. Most common associated featureswere vertigo and headache.

Ø  GroupA (Virechana followed by Shamana) and Group B (Basti followed by Shamana) showed comparatively more improvement in clinicalmanifestations as compared to only Shamana(Masha Baladi Kwatha) treatment, i.e.Group C. These changes were statistically significant.

Ø  Bastiprovided relatively better improvement in the quality of life and in themanagement of higher mental functions.Basti was found to be more effective in management of Infarct cases whilehemorrhagic cases were better addressed by Virechana.

Ø  Virechanafollowed by Shamana, managed Motorfunctions better than Basti followedby Shamana. Prognosis was better inthe patients of younger age group and lesser chronicity.

Ø  Safeapplication of Basti and Virechana was demonstrated throughanimal study. No pathological findings were reported in the histopathologicalstudy.

Ø  Virechanaand Basti showed lipid loweringeffects after pharmacological study. Findings were more prominent in Basti group which was statisticallysignificant.

 Selected samples of Virechana and Basti were analyzed for Gene expression changes.

Ø  Manygenes and signaling pathways were differentially expressed which had asignificant role in relation to Stroke. This differential expression wassignificant as the first stride to establish Panchakarma therapies at amolecular level.

Ø  Moreprotein translation functions were expressed in Basti samples than Virechana.

Ø  Ayurgenomicsstudy also showed the importance of Snehapanaand Samsarjana krama during Shodhana dueto varied expression at different stages which actually justifies the extremeimportance laid on management during Shodhanaoperations and thereafter.

Ø  Thisdifferential expression at Genomic levels may be a significant lead and pavethe way for future studies for more extensive research to find a confirmatoryrelationship between Stroke management through Panchakarma therapieslike Basti and Virechana.

Ø  Somepathways related to other diseases like Cancer, Alzheimer’s, Parkinson’sdisease, Rheumatoid Arthritis etc. were also differentially expressed after Virechana and Basti, so these can also be considered for similar research infuture.

ü  Finally,the Null hypothesis (H0) which stated that-Shamanaafter Virechana and Shamana after Basti and only Shamana areequally effective in Pakshaghata, wasrejected.

ü  Alternatehypothesis (H2) stating that -Shamanaafter Basti is more effective in themanagement of Pakshaghata than shamana after Virechana or only Shamana,was accepted.

Therefore, we may conclude that Shamana after Basti in Pakshaghata was comparatively moreeffective considering the Clinical, Pharmacological and Ayurgenomicsparameters.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • diagnosed cases of pakshaghata yogya for virechana and basti karma.

排除标准

  • degenerative lesions intracranial infection intra cranial spae ocupying lesion.

结局指标

主要结局

to improve the disability produced by pakshaghata

时间窗: 7 to 8 weeks

次要结局

  • to improve quality of life of patients and assess signs and symptoms after four weeks(four weeks)

研究者

发起方
IPGT RA GAU JAMNAGAR GUJARAT
申办方类型
Research institution and hospital

研究点 (1)

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