跳至主要内容
临床试验/CTRI/2025/02/081454
CTRI/2025/02/081454尚未招募2/3 期

Randomized Controlled Clinical Study To Evaluate The Effect Of Triphaladi Arka In Neonatal Hyperbilirubinemia

Dr SANJAY K SOLANKI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月17日最近更新:

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

发起方
Dr SANJAY K SOLANKI
申办方类型
Other [SELF FUNDED]
责任方
Principal Investigator
主要研究者

Dr Sanjay K Solanki

Rajiv Gandhi University Of Health Sciences,Banglore

研究点 (1)

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