Evaluation of changes in the quality of Asthi Dhatu on administration of Panchatikta Ghruta Guggulu in middle aged osteoporotic individuals of different Deha Prakriti
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in 3D DXA BMD
研究概览
简要总结
INTRODUCTION:As per Ayurveda, body is formed of Dosha, dhatu and mala.Among the seven dhatu, asthi dhatu isthe fifth one which is having thefunction of giving support and stature to the body in normal condition. Whenthe quantity or quality of asthi dhatu varies it reflects as various signs and symptomsin the body. The increasein asthi dhatu results inovergrowth of bones and teeth whereas the depletion in asthi dhatu causes falling of teeth, nails, body hairs and scalphairs, dryness, roughness, looseness of joints, pricking pain in bones and desire for the meat attachedto bones as food.Asthijanyavikara is recommended to be treatedwithtiktadravya and ksheeravastimade of *tiktadravya.*Now a day, the incidence of asthivikara is increasing enormously but usually in the initial stagesit remains unnoticed.
Osteoporosis is a condition in which bones become weakand brittle. Normally, the body constantly absorbs and replaces bone tissue.With osteoporosis, new bone creation doesn’t keep up with old bone removal. Thequality of bones changes where bone mineral density and bone mass decreases,eventually leading to bone fracture. But it is a silent disease that manypeople have no symptoms until they have a bone fracture. Osteoporosis canaffect people of any age and ethnic group, but more prominent in old age andpost-menopausal women. The most common test for measuring bone mineral density is dual-energyx-ray absorptiometry (DXA). It is a quick, painless, and non-invasive test. DXAuses low levels of x-rays as it passes a scanner over body of the subject lyingin supine position on a cushioned table. The test measures the BMD of skeletonand at various sites that are prone to fracture, such as the hip and spine.Bone density measurement by DXA at the hip and spine is generally consideredthe most reliable way to diagnose osteoporosis and predict fracture risk. Treatment of osteoporosis includes medication, a healthy diet andweight-bearing exercise to help prevent bone loss or strengthen already weak bones. Dual Energy X-rayAbsorptiometry is a widely accepted reference parameter to measure bone mineraldensity (BMD) at the spine and hip helping in diagnosing osteopenia, osteoporosis etc.
Prakriti is the unique concept of Ayurveda to assess the characteristicfeatures of individuals based on their physical, psychological and physiological parameters. Simply prakriti can be said as the nature of an individual.It describes how a person is different from another individual. It ispredetermined at the time of conceptionbased on the predominance of doshas and remains unchanged throughout the life.It is the prime tool among dasavidhapareeksha for examining apatient. Considering the prakriti of an individual only, physician can arrive at a conclusion of choice of medicine,dosage, time and medium of administration. Inshort, we can say Prakriti isthe Ayurvedic phenotyping method to categorize and identify people. Every person has his/herown unique constitution which determines the biological functions, response to environmental factors, drugs and alsosusceptibility to diseases making it one of the earliest known concepts of preventive and personalized medicine.
**PREVALENCE:**Worldwide, it is estimated that 1 in 3 womenabove the age of 50 will experience osteoporotic fractures, as well as 1 in 5men. Studies indicate that osteoporosis and osteopenia or low bone mass mayoccur at a relatively younger age in Indian population. From India, reported prevalence ofosteoporosis from various studies amongwomen is 8 to 62%. This shows wide variation in prevalence across India. Further, the risk of osteoporosis is higher in women than men and in elderlythan young adults. In line with this,recent study from North India reported higher osteoporosis prevalence in women(3 and 36.4% women aged 30 to 39 years and >70 yearsrespectively) than men (0 and 5.6% for the two age groups respectively). A study in Delhi estimated the prevalence of osteoporosis as 24.6% inmen and 42.5% in women above 50 years of age.
NEED OF STUDY:This alarming rise in bone disorder should be rightlyaddressed, otherwise the health of the future generation will be at stake succumbing to early osteoporosis and subsequentbone fractures. As per Ayurveda, many drugs and formulations have been mentionedfor the management of asthijanyavikara. PanchatiktaGhrutaGugguluis a proven formulation mentioned in BhaishajyaRatnavali. Dr. Ritesh et alhas established the efficacy of PanchatiktaGhruta Guggulu in osteoporosis and its positiveeffect on asthimajjadhathu7.Though it has been proved that PanchatiktaGhruta Guggulu is having significant effect in improving the qualityof asthi dhatu, it has not been proved that whetherthe effect of Panchatikta Ghruta Guggulu on thequality of asthi dhatu variesdepending on prakriti of individualand if it varies, to what extent. Thebioavailability of drugs, their metabolism and absorption rate etc may vary accordingto the prakriti of an individual. If some concludingfindings can be made out on the effectiveness of this medicine based on prakriti ofindividual, it would help in the management of osteopenia, osteoporosis like asthikshayajanyavikara in a much focused andbetter modulated way. In this study individuals in the middle age group are thetargets. As per Ayurveda classics,middle age is from 30 to 60 years. But the period of 30-40 years is of dhatusampoornata and after the age of 40 years only dhatukshaya occurs. So, here individuals of the age in the category40-60 years are selected for the study8.
This study is an attemptto assess the influence of prakriti in the responseof asthi dhatu to Panchatikta Ghruta Guggulu by administering PanchatiktaGhruta Guggulu in middle aged individuals of differentdehaprakriti who are diagnosed as having osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals who are identified as dwandwaja prakriti (not more than 10% difference between the predominant dosha and at least 10% difference with the least predominant dosha) Individuals who are identified as having osteoporosis with respect to BMD T score (T score < -2.5).
排除标准
- •Individuals under any medication for systemic illnesses like morbid HTN, diabetes, Chronic respiratory illnesses etc.
- •Individuals who are under any hormone therapy/ steroids etc.
- •Individuals with any acute or chronic joint diseases like Gouty Arthritis, Rheumatoid arthritis etc.
- •Individuals with identified bone TB, bone tumor, osteomyelitis, osteomalacia, Paget’s disease etc.
结局指标
主要结局
Improvement in 3D DXA BMD
时间窗: On day 1 and ON 46th day
Serum Calcium
时间窗: On day 1 and ON 46th day
Vit D
时间窗: On day 1 and ON 46th day
次要结局
- changes in the quality of Asthi Dhatu on administration of Panchatikta Ghruta Guggulu according to Dehaprakriti(Day 1 and on Day 46)
