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临床试验/CTRI/2024/03/064680
CTRI/2024/03/064680已完成3 期

Efficacy Of Virechana Karma Followed By Triphladi rasayana And The Triphaladi rasayana Only In The Management Of Pre Mature Ageing(Akalaja Jara)–An Open Labelled Randomized Comparative Clinical Trial

Institute Of Teaching and Research In Ayurveda ,JAMNAGER1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
There will be Improvement in SF 36 score After Completion of Treatment.

研究概览

简要总结

The title of our research project is“EFFICACY OF VIRECHANA KARMA FOLLOWED BY TRIPHALADI RASAYANA AND TRIPHALADI RASAYANA ONLY IN THE MANAGEMENTOF PRE MATURE AGEING(AKALAJA JARA)–AN OPEN

LABELLED RANDOMIZED COMPARATIVE CLINICAL TRIAL”

Introduction:

Ageing is progressive physiological changesin an organism thatlead to decline of biological functions and of the organism’s ability to adapt to metabolic stress.According to WHO the elderly has been defined as the chronological age of 60 year. Due to Exposure to UV radiation, long-term stress conditions, lack of physical exercise, improper diet and use of stimulants by this Excessive formation of free radicals which contributes to oxidative stress, causing damage at the molecular and cellular level. Reactive oxygen species in vitro cause chemical modifications as well as damaging effects to proteins , lipids, carbohydrates and nucleotides , which can contribute to pre mature ageing.

The Triphaladi rasayana is mainly concerned with immune system strengthening which “Reduce oxidative stress, boost antioxidant defenses, and promote rejuvenationiv. Sodhanais necessory prior to rasayana to increase effect of Rasayana.

Significance:As the incidence of premature ageing is increasing globally, it has become a burning issue to take major steps for its prevention and treatment. Conventional system of medicine has limited approach regarding its prevention and treatment. In Ayurveda, Geriatrics is considered as a separate branch among 8 branches of Ayurveda, is limited approach regarding its prevention and treatment. In Ayurveda, Geriatrics is considered as a separate branch among 8 branches of Ayurveda, is also becoming a major medical speciality globally. Yet there is a necessity for persuing further research to find out some safe and effective therapy. Taking all above fact into consideration, this topic was

selected to find a measure that could help to improve quality of life.

Aim & Objectives:

To assess and compare the efficacy of Virechana karma and Triphaladi rasayana in Pre mature

ageeing (Akalaja jara).

Materials and Methods:

30 Patients of Pre Mature Ageing will be enrolled in two groups. Group A patients will receive intervention Virechana karma followed by Triphaladi rasayana.Group B patients will receive

Triphaladi rasayana.

Results and Discussion:

Results: Virechana followed by Triphaladi Rasayana (Group A) produced significant and widespread improvements in facial wrinkles, particularly in the forehead, glabellar, periorbital region, cheeks, nasolabial folds, upper lip, corners of the mouth, and neck, with minimal changes in preauricular and lower lip lines. These improvements persisted after 15 days of follow-up. Triphiladi Rasayana alone (Group B) showed modest improvement in wrinkles, mainly in the forehead and periorbital lines. Both groups showed highly significant improvement in SF-36 scores, while Group A demonstrated superior outcomes in wrinkle reduction and Grey/White Hair Score compared to Group B, indicating overall better effectiveness of the combination therapy.Discussion: Premature ageing (Akalaja Jara) results from Pitta-pradhana Tridosha aggravation causing Agni imbalance, Srotorodha, and Dhatu-ksaya, with Pittaja prakriti individuals being more susceptible; Virechana Karma clears Pitta and Srotorodha, Triphaladi Rasayana nourishes Dhatus and delays degeneration, and their combination shows superior improvement in wrinkles, hair pigmentation, and quality of life

Follow up: After completion of therapy, follow up will be done after 15 day to assess the status of patient, where patient will be asked to report.

Adverse effects:

This drug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

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
30.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to paricipate in the study.
  • Patients indicated for virechana karma.

排除标准

  • Patient with any type of psychiatric disorder like Alzheimers diseases,parkinsonism .
  • Patient with any systemic diseases like uncontrolled hypertention,diabetes mellitus,tuberculosis,carcinoma ,or any genetic disorder and syndromes.
  • Patient contraindicated for Virechana karma.

结局指标

主要结局

There will be Improvement in SF 36 score After Completion of Treatment.

时间窗: Group A 44 to 54 days | Group B 30 days

次要结局

  • grey/white hair scale score and Facial Wrinkles score(44 TO 54 DAYS in GROUP A)

研究者

发起方
Institute Of Teaching and Research In Ayurveda ,JAMNAGER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Pratiksha V Sayani

Institute Of Teaching and Research In Ayurveda ,Jamnagar

研究点 (1)

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