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临床试验/CTRI/2020/07/026939
CTRI/2020/07/026939已完成2 期

A Comparative Clinical Study to Evaluate the Efficacy of Vrishyamuladi Taila and Shatavari Taila Matra Basti with Vyoshadhya Gutika Guggulu in the Management of Asthi-Majja-Kshaya w.s.r. to Low Bone Mineral Density

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月8日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Improvement in Bone Mineral Density

研究概览

简要总结

INTRODUCTION

BMD refers to Bone Mineral Density, a measure of bone density, reflecting the strength of bones. It detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss) when performed. It measures bone density or mass compared to a healthy person of the same age and gender. BMD measurements, known as T-scores, determine bone density and reveal whether it is normal, osteopenia (low bone mineral density), or osteoporosis (more severe low bone mineral density).

Low bone mass that isn’t precisely osteoporosis is referred to as osteopenia. It is a condition in which bone mineral density is lower than average. It’s thought to be a precursor to osteoporosis. Osteoporosis is a widespread clinical condition affecting multiple bones in which bone tissue density is reduced quantitatively, resulting in a brittle skeleton.

Osteopenia, often known as low bone mass or low bone mineral density, is an ailment in which the bone mineral density is low. Due to the bone being weaker, it can increase the likelihood of fracture and may lead to osteoporosis later in life.

Osteoporosis is a worldwide public health concern wherein the number of people with osteoporosis and fractures is expected to increase as the number of elderly people in developed and developing countries grows. Strong bones are essential for our health since they play a vital part in the body’s overall function. Moreover, as they provide a frame for the body and protect vital organs such as the heart and other organs, they also offer support and structure.

Ayurveda is one of the most ancient medical sciences in the world. It conceives and describes the basis & applied aspect of life process, health, disease & its management in terms of its principles & approaches. There is no exact clinical entity mentioned in Ayurvedic classics like low bone mineral density or osteoporosis; however, the bone conditions Asthi-Kshaya and Asthi Saushirya have some clinical resemblance. Asthi-Saushirya is mentioned as a Majja-Kshaya, whereas; Asthi-Kshaya is cited as an independent condition. Asthi-Kshaya is ‘decrease in the bone tissue’ and Asthi-Saushirya means’ porous bones.’ Hemadri has commented on the word ‘Saushirya’ as ‘Sarandhratvam,’ which means ‘with pores.’ This condition is explained in the context of Majja-Kshaya. Asthi, considered as the major seat of Vayu and the condition of Asthi-Majja-Kshaya can lead to aggravated Vata Dosha.

Acharya Charaka has advocated the use of Snehana for aggravated Vata in Asthi and Majja Dhatu. He has indicated Basti as the Ardhachikitsa for the Vataj disorders and in Asthi-Kshaya. Aggravated Vata Dosha is responsible for the pathogenesis of Asthi-Majja-Kshaya. Considering osteopenia and osteoporosis as a degenerative Vata dominant bone disorder, the present clinical study was planned to evaluate the efficacy of Matra Basti and Shaman Chikitsa mentioned in the treatment of Vatavyadhi. For Matra Basti, two oil-based formulations*,* viz*: Vrishyamuladi Taila* and Shatavari Taila, were selected for evaluating the comparative efficacy, whereas, for Shaman, Vyoshadhya Gutika Guggulu was selected as indicated in the treatment of Asthi-Majja-Kshaya.

WORK PLAN

GROUPING: Subjects were randomly divided into two groups:

Group A: 17 Patients in this group were givenVrishyamuladi Taila Matra Basti and Vyoshadhya Gutika Guggulu

Group B: 17 Patients in this group were givenShatavari Taila Matra Basti and Vyoshadhya Gutika Guggulu.

ASSESSMENT: On the basis of BMD score and Ayurvedic Parameters, assessment was done before treatment, after treatment and during last follow up.

PROCEDURE:

Group A: Patients in this group were givenVrishyamuladi Taila Matra Basti and Vyoshadhya Gutika Guggulu

a. Sthanik Abhyang and Swedan was done for 16 days during the morning period,  before administering Basti.

b. Vrishyamuladi Taila Matra Basti, in the dose of 60 ml, once daily was administered through rectal route as per “Kala Basti†schedule, for 16 days.

c. Vyoshadhya Gutika Guggulu was administered in the dose of 1g twice a day orally with lukewarm water for 30 days, after Basti was completed.

Group B: Patients in this group were givenShatavari Taila Matra Basti and Vyoshadhya Gutika Guggulu.

a. Sthanik Abhyang and Swedan was done for 16 days during the morning period, before administering Basti.

b. Shatavari Taila Matra Basti, in the dose of 60ml, once daily was administered through rectal route as per “Kala Basti†schedule, for 16 days.

c. Vyoshadhya Gutika Guggulu was administered in the dose of 1g twice a day orally with lukewarm water for 30 days, after Basti was completed.

Effect of Therapy on Subjective Parameters in Group A:

There was a 41.94% improvement reported in Asthishoola (bone pain), followed by 54.17% improvement in Asthitoda (pricking pain in bone), 50.00% improvement was noted in Nakhabhanga (splitting of nails), 42.86% improvement was noted in Raukshya (dryness), 47.62% improvement was noted in Aswapna (loss of sleep), 52.63% improvement was noted in Satataruka (continuous pain).

 Effect of Therapy on Subjective Parameters in Group B:

There was a 52.78% improvement reported in Asthishoola (bone pain), followed by 46.88% improvement in Asthitoda (pricking pain in bone), 54.55% improvement was noted in Nakhabhanga (splitting of nails), 50.00% improvement was noted in Raukshya (dryness), 46.43% improvement was noted in Aswapna (loss of sleep), 39.29% improvement was noted in Satataruka (continuous pain).

  Effect of Therapy on Objective Parameters in Group A:

There was a 4.69% improvement observed in Vitamin D3, then 1.06% improvement was observed in Serum Calciumand 1.49% improvement was observed in BMD levels*.*

Effect of Therapy on Objective Parameters in Group B:

There was a 4.43% improvement observed in Vitamin D3, then 1.16% improvement was observed in Serum Calciumand 1.87% improvement was observed in BMD levels*.*

Comparison of Objective Parameters between Group A and Group B

It was observed that there is no significant difference in any of the parameters tested in both the Group A and Group B comparisons.

Conclusion

Ø  It is concluded that there is no difference between the effect of Vrishyamuladi Taila Matra Basti and Shatavari Taila Matra Basti followed by Vyoshadhya Gutika Guggulu in the Management of Asthi-Majja-Kshaya (Low Bone Mineral Density).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to sign consent form for trial.
  • Patients of either sex in the age group 30 to 60 years.Patients presenting with classical features of Asthi-Majja-Kshaya.
  • Patients of Low Bone Mineral Density diagnosed by BMD (Bone Mineral Density) pDEXA test; BMD Score (T Score between -1 to -2.5 SD).

排除标准

  • Patient below the age of 30 and above 60 years.
  • Patient suffering from any systemic disorder like Diabetes Melllitus (uncontrolled), Hypertension (uncontrolled), Endocrinal disorders, Hyperparathyroidism, Paget’s disease, Cushing syndrome, Marfan Syndrome, Thyrotoxicosis, Osteogenesis Imperfecta, Homocystinuria.
  • Patient suffering from pathological osteoporosis or any neoplasm or osteoporosis related to systemic disorders.
  • Osteoporosis associated with fracture.
  • Patients not willing to sign consent form for trial.

结局指标

主要结局

Improvement in Bone Mineral Density

时间窗: Baseline (day 0), Day 75

次要结局

  • Relief in pain and other symptoms.(75 days)

研究者

申办方类型
Government medical college

研究点 (1)

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