Randomized Controlled Clinical Study To Evaluate The Effect Of Triphaladi Arka In Neonatal Hyperbilirubinemia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Samples Of Blood Will Be Collected In Two Groups Of New Borns
研究概览
简要总结
Neonatal hyperbilirubinemia is the most common clinical condition seen in contemporary science, this accounts for 60 percentage cases in term babies and 80 percentage in preterm babies during the first week of life and is a common cause of mortality and morbidity in newborns The yellowish discoloration of sclera and skin of a newborn is due to the breakdown of hemoglobin It can
be physiological or pathological Physiological Neonatal Hyperbilirubinemia occurs on the second day of life due to several causes like physiological polycythemia shorter life span of RBC reduced hepatic uptake conjugation and excretion of bilirubin or increased enterohepatic circulation Pathological Neonatal hyperbilirubinemia occurs within the first day of life due to Rh incompatibility ABO incompatibility deficiency of G6PD enzyme hypothyroidism or sepsis
If Neonatal hyperbilirubinemia is not treated it may lead to kernicterus and encephalopathy causing irreversible brain damage Phototherapy is the gold standard in management of neonatal hyperbilirubinemia however it has significant complications It can hinder breast milk secretion interfere with mother child bonding and also cause loose stools hydration and electrolyte imbalance bronze baby syndrome retinal damage and parent anxiety in the short term The long term complications include impotency DNA damage leading to melanoma and skin cancer and allergic diseases like asthma and atopic dermatitis Thus there is a need to find an alternative for reducing the use of phototherapy
In Ayurveda Kamala is a Pittaja Nanatmaja Vyadhi as well as a Rakta Pradoshaja Vikara
Even though there is no chapter dedicated to Navajatha Sishu Kamala we get scattered references The clinical features of Kamala described in Kashyapa Samhitha Vedana Adhyaya are similar to the features of neonatal hyperbilirubinemia The main cause for kamala is Pittaja Stanya Dusti which causes yellowish discoloration Therefore Pitta Shamana is the choice of treatment for Kamala The newborn period is an age where Shodana karmas like Virechana are contraindicated Thus palliative care can be provided
Triphaladi arka is one such shamana aushadi mentioned in the Ashtanga Sangraha and Ashtanga Hrudaya in the context of Pittaja Stanya Dusti Chikitsa
Triphaladi arka consist of six drugs namely Triphala Bhoonimba Musta and Katurohini Triphala has Pitta Hara and Anulomana Properties It can be used for treating Kamala in newborns because of its unique combination that is Amalaki which has Sheeta Virya and Madhura Vipaka and Haritaki and Vibhitaki which have Kashaya Rasa and Madhura Vipaka Katurohini and Bhoonimba have Yakrut Roga Hara
properties Bhoonimba due to Tikta Rasa and Musta and Katuki due to Sheeta Virya and Tikta Rasa act as Pitta Shamaka
In brief Triphaladi Arka contains drugs with Pitta Kapha Hara and Anulomana properties which break down the pathogenesis of Navajatha Kamala In this study we will evaluate the efficacy of Triphaladi Arka in neonatal hyperbilirubinemia
Arka Preparation is a special preparation method Compared to other drug forms it is more potent and palatable with a longer shelf life and faster action Arka kalpana of Triphala etc will therefore help to preserve all the volatile active principles of the drugs and can be administered in smaller doses making it the ideal dosage form for newborn babies
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
- 0.00 Day(s) 至 6.00 Day(s)(—)
- 性别
- All
入选标准
- •Healthy neonates of either gender, irrespective of caste and creed extracted through LSCS.
- •Term neonates with body weight between 2500 to 3500 grams.
- •Neonates, whose parents are willing to give consent for the trial.
排除标准
- •Newborn with birth asphyxia or with APGAR score less than 7 Newborn with congenital anomalies Newborns with any medical or surgical illness.
结局指标
主要结局
Samples Of Blood Will Be Collected In Two Groups Of New Borns
时间窗: Samples Of Blood Will Be Collected In Two Groups Of New Borns | New Borns Will be Assessed For Serum Bilirubin And Kramers Rule At Interval Of Birth Day , Second Day, Fourth Day And Sixth Day
First Group Will Be Intervened With Triphaladi Arka Along With Routine New Born Care And Second Group Will Be Control Group Who Will Be Given Only New Born Care
时间窗: Samples Of Blood Will Be Collected In Two Groups Of New Borns | New Borns Will be Assessed For Serum Bilirubin And Kramers Rule At Interval Of Birth Day , Second Day, Fourth Day And Sixth Day
次要结局
- To Evaluate The Effect Of Triphaladi Arka In Neonatal hyperbilirubinemia(Assessment Of Serum Bilirubin And Kramers Rule At Intervals Of Birth Day, Second Day , Fourth Day And Sixth Day)
研究者
Dr Sanjay K Solanki
Rajiv Gandhi University Of Health Sciences,Banglore
