跳至主要内容
临床试验/CTRI/2025/02/080595
CTRI/2025/02/080595尚未招募不适用

An open label randomized control clinical study to evaluate the effect of kushmanda swarasa and kapittha swarasa as pathya in amlapitta

Dr Tejaswini R1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Relived from symptoms of amlapitta

研究概览

简要总结

NEED FOR STUDY

In this developing era, due to mechanical lifestyle, people are practicing poor and inappropriate dietary habits with processed food resulting in Agnimandhya and Ama which combines with Pitta cause inflammation to the gastric mucosa leading to Amlapitta. This is a common Annavaha SrotoDushti Vikara, also known as Hyperacidity, is a set of symptoms caused by an imbalance between the acid secreting mechanism of stomach and proximal intestine and the protective mechanisms that ensure their safety. The stomach normally secretes acids essential in the digestive process, excess production of which results in Hyperacidity. About 32% of adults aged 30-44 years have reported having acidity and indigestion problem by survey conducted in India in 2021.

Prolonged use of antacid to manage hyperacidity, leads to inhibition of absorption of Iron,      Calcium, and Phosphates, Milk-Alkali Syndrome, Impotency, Gynecomastia, Liver Damage, increase risk of Cancer.  Ayurvedaemphasizes basic dietary guidelines in prevention and management of disease. The Ahara which are congenial to channels, constitution and strength of individual is Pathya Ahara. The impact of Amlapitta on Annavaha srotas is direct and is a psychosomatic disorder and dietary indiscretion plays significant roles. Ahara Dravyas as Amlapitta Pathya have been mentioned in Bhaishajya Ratnavali which are Purana shali, Yava, Mudga, Tapta Sheeta jala, Karavellaka, Patola leaves, Saktu, Kapittha  Kushmanda and Dadima.  There is a need of Pathya Ahara for excess use of antacids, hence with this background the present study will be conducted to know the efficacy of Kushmanda Swarasa and Kapittha  Swarasa as Pathya in Amlapitta .

REVIEW OF LITERATURE·       According to ShabdhakalpadhrumaAhara is the substance which is ingested which includes food anddrinks.

·       According to Charaka Samhitha– Food is the vital breath of living beings (that is why) the people rush to the food. Complexion, cheerfulness, good voice, life imagination, happiness, contentment, corpulence, strength, and intellect, all these are dependent on food.

·       According to Charaka SamhithaPathya is that which is not harmful to the paths (of the body) and is according to liking.

·       According to Gangadhara– The drugs and regimen which do not adversely affect the mind are considered as Pathya. Also, that which is wholesome to channels of the body or Srotases is called Pathya.

·       The word Amlapitta is composed of 2 words Amla +Pitta – Amlapitta.

·       Amlapitta is one of the common problems of Annavaha Srotas.

·       According to Madhava nidhana etiology. The pitta which has already accumulated in body gets further aggravated by consuming incompatible food combination, putrefied foods, sour foods, over burnt foods and pitta aggravating foods and drinks and is called Amlapitta.

·       In Amlapitta (Hyperacidity), the Quantity of Pachaka Pitta gets increased and it changes from normal bitter taste to sour taste.

·       In Madhukosha -The increase of Vidagda (burnt away) pitta is Amlapitta and that Vidagdha pitta undergoes fermentation and becomes sour (amlibhava) and causes Amlapitta.

·       According to Bhaishajya Ratnavali- One can include Kapittha and Kushmanda in their diet.

·       Kapittha- Limonia accidissima. This belongs to Rutaceae family, is a small deciduous glabrous    tree or medium sized tree up to 30 meter tall, armed with strong straight axillary thorns. Seed many, not be covered by mucilage, embedded in sour, tasty, fleshy, pulp fruits globose grey, rough, 2-3 inch diameter, rind hard, woody, fruit pulp edible. It is having Madhura-Amla rasa, Laghu-Ruksha Guna , Sheetha Virya and Katu Vipaka. It has TridoshaharaVatapitta Shamaka activity. Useful part fruit, leaves, flowers, bark, root and gum.

·       KushmandaBenincasa hispida. Which belongs to Curcurbiraceae family*,* is an annual branched climbers, extensive, trailing or climbing herb. Fruits fleshy, hairy when young, waxy bloom when mature, fruits broadly cylindrical or spherical gourd, 1-1.5 ft. long with white flesh, containing numerous, much compressed and marginal seeds. It is having Madhura rasa, Laghu-Snigdha Guna, Sheetha Virya, Madhura Vipaka. It has Vatapitta Shamaka, Sarvadoshahara (pakva fruit).

6.3  AIMS & OBJECTIVE OF THE STUDY1.     To evaluate the effect of Kushmanda Swarasa (Benincasa hispida) in Subjects of Amlapitta as Pathya .

2.     To evaluate the effect of Kapittha Swarasa (Limonia  accidissima) in Subjects of Amlapitta as Pathya .

3.     To compare the effect of Kushmanda Swarasa (Benincasa hispida) and Kapittha Swarasa (Limonia  accidissima) in Subjects of Amlapitta as Pathya .

A.  Diagnostic criteria:

Subject will be selected with cardinal features of Amlapitta like Hrit Kanta  daha, Tiktha Amlodhgara,  Klama, Utklesha, Avipaka, along with or without the following symptoms of Urdhwaand Adhoga Amlapitta .

Chardi .

Aruchi .

Shiroruja.

Vibandha. Adhmana

A. Assessment criteria:Assessment is done on subjects based on below parameters. •        Hrit Kanta  daha .•        Tiktha amlodhgara. •        Klama .•        Utklesha.•        Avipaka. •        Chardi .

•        Aruchi.

•        Shiroruja.•        *Vibandha.*Adhmana

Plan of treatment:

After taking informed consent 50 subjects will be assigned into Group A and Group B.

GROUP A

•        Sample size – 25 subjects.

•        Procedure – Subjects will be Administered Kapittha swarasa (Limonia accidissima) 25ml twice daily before food for 30 days.

GROUP B

•        Sample size – 25 subjects.

•        Procedure – Subjects will be Administered Kushmanda swarasa (Benincasa hispida) 25ml  twice daily before food for 30 days

Method of preparation of Kushmanda swarasa*(Benincasa hispida)* -

Procedure – Fresh fruit of Kushmanda (Benincasa hispida)  will be  taken cut into small pieces , the kalka is made and blend, swarasa is extracted .

Method of preparation of Kapittha swarasa*(Limonia accidissima)* –

Procedure – Fresh fruit of Kapittha (Limonia accidissima) is taken, the pulp is scrapped and kalka is made and blend, swarasa is extracted.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Subjects fulfilling the diagnostic criteria of Amlapitta, Subjects who are willing to participate in the study.

排除标准

  • Known case of gastric and duodenal ulcers, Subjects who have undergone gastric surgery, Gastritis which interfere with the treatment, Subjects with gastric malignancies.

结局指标

主要结局

Relived from symptoms of amlapitta

时间窗: 4 week

次要结局

  • No recurrence of symptoms of amlapitta(60th day)

研究者

发起方
Dr Tejaswini R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tejaswini R

JSS Ayurveda medical college and hospital, Mysuru

研究点 (1)

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