Randomized controlled clinical trial to evaluate the efficacy of Nimbadi taila in the management of garbhini kikkwis (striae Gravidarum)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Classical signs and symptoms of Striae Gravidarum decreses
研究概览
简要总结
Ayurveda is a science of life , which gives importance to both preventive and curative aspects of disease , enriched with various medicinal herbs for the management of different
disorders by external and internal use.
Pregnancy is a very beautiful time in a women’s life. Duringpregnancy there are profound anatomical and physiological changes to adopt and support the entire period of 9 months of
pregnancy.
Kikkwis is a clinical entity which appears in the 7th month of pregnancy , characterized by Kandu (itching) , Vidaha (burning sensation) and Rekhaswaroopa Twak Vidaran ( linear Striae)
found on the Udara (Abdomen) , Stana ( Breast) and Uru (Thigh) region due to growing foetus and stretching of abdominal skin.
It can be correlated to Striae Gravidarum in contempory science
Garbhini Kikkwis has been described in Charak Samhita , Ashtang Sangrah , Ashtang Hrudaya and Bhel Samhita .
According to Charak, due to growth of scalp hairs of the foetus in the seven month.
The mother get vidaha ( burning sensation) resulting into development of Kikkwis. However,
Atreya says, no it’s not so the growing foetus displaces the Doshas upward reaching
Uras(chest) produces Vidaha and Kandu
Aacharya vagbhat follows the concept of Charak but states that Doshas resides in
Hridaya (Heart) causes itching and burning.
Chakrapani opinions that growth of hair can not be the cause as these start developing from third month itself.
Arundatta has included burning sensation of palm and sole also as a symptom.
The vitiated pitta is seen to produce its effect first causing vidhah and subsequently kandu which is due to vitiation of Kapha. These two doshas when they vitiate Vaata to a greater extent and then produce vidaran of the Twak.
According to modern science, Striae Gravidarum usually occurs during second trimester of pregnancy. Seven month onward the uterus enlarged due to growing foetus and produces stretching of abdominal skin, due to this stretching linear lines appear over the skin of abdomen, breast and thighs .
Initially Striae Gravidarum are pinkish but after delivery the scar tissues contract and obliterate the capillaries and they become glistening white in appearance. These stretch marks represents the scar tissues in the deeper layers of cutis.
Antenatal itching leads to irritability and disturbance of pregnant women’s body and mind while postnatal persistence of permanent stretch marks also cause crude appearance,
depriving her of confidence and looks.
In modern science; this condition is treated with antihistaminic drugs and steroids for its symptomatic relief and second option is surgery i.e. abdominoplasty and laser surgery. This line of treatment not only expensive but also having many side effects. Hence, there is a need for herbal medicines for the management of Garbhini Kikkwis which is cost effective and with less side effects.
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
- 7.00 Month(s) 至 9.00 Month(s)(—)
- 性别
- Female
入选标准
- •Patients willingly participating in the trial and giving Consent form.
- •Patients with gestational age of 28 weeks onward upto Delivery.
- •Patients having classical sign and symptoms of Kikkwis as per prepared Performa will be selected.
- •Primi gravida patients will be selected for study.
排除标准
- •Patients not willing to participate in the trial.
- •Patients having Skin disease will be excluded.
结局指标
主要结局
Classical signs and symptoms of Striae Gravidarum decreses
时间窗: Baseline-15th,30th,45th,60th
次要结局
- Discoloration of Striae(2 months)
研究者
Dr Shubhangi Balajirao Kshirsagar
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra
