跳至主要内容
临床试验/CTRI/2024/10/075753
CTRI/2024/10/075753尚未招募2/3 期

Evaluation of comparative efficacy of Rasona Ksheerapaka versus Clomiphene Citrate in the management of anovulation induced infertility - RCT

MGACHRC, SALOD, WARDHA1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年11月5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
66
试验地点
1
主要终点
To evaluate the ovulatory effects of trial drug

研究概览

简要总结

“A women’s life is incomplete without her being transformed into a mother…….”Many of us may claim that this quote is not universal. Although, one cannot deny that being a mother is dream of most of the women. Failing to ovulate has become one of the commonest cause of infertility. Clomiphene Citrate has become popular for the condition. However, it has shown potent results, it also has numerous side effects such as ovarian hyper stimulation syndrome, ovarian cyst, multiple pregnancies and resistance to treatment etc. On the other hand, it doesn’t work on womb preparation and hence patient have to consume estrogens which possess other adverse effects. Due to such reasons patients with anovulation are eventually left with the only option to opt for IVF (In Vitro Fertilization) which cannot be afforded by everyone. Here, Ayurveda can be savior for such patients, as Acharya Kashyapa has elaborated use of Rasona in patients with Beej related diseases1. Among the causes of female infertility, anovulation is becoming commoner and shares about 25% of prevalence. One can say that every female encounter anovulation at some times during her fertile age2. Clomiphene Citrate remains the drug of choice in modern medicine for those who does not respond to hormone therapy regimen. Approximately, 50 – 80 % women ovulate after taking clomiphene citrate but the pregnancy rate is nearly half of the ovulation.           Classical Ayurvedic literature has numerous references which can be co-related with the said entity, viz; Beejopaghata, Pushpopaghata, Abeeja etc. Acharya Kashyapa has claimed that Rasona has Shonitajanana properties which is nothing but Stribeeja (i.e. ovum) and also supports growth of Garbha3. He has devoted a whole chapter in his Samhita for use of Rasona in management of Vandhyatva. He has described many formulations of Rasona in combination with various drugs. It is also beneficial for prevention of menstrual diseases, pelvic disorders and infertility too4. Acharya Kashyapa has recommended use of Rasona in various forms such as crude garlic bulbs fried in ghee, in the form of dumplings made from different vegetables leaves, meats, Yawagu, curds, etc. treated with Rasona. Besides these oral preparations, he has recommended use of Ghrita, Taila, etc. medicated with Rasona for oral use and Basti also5. In short Acharya Kashyapa has acclaimed to use Rasona in various forms or formulations or routes, that’s why in this study scholar is intended to study use of Rasona Ksheerapaka in female infertility.          In the previous study conducted by the scholar in 2009, Rasona Tail Uttarbasti (intra uterine instillation of oil) and Rasona Sidhha Ksheera were compared with Clomiphene Citrate and it was evidenced that the trial group was effective in regularizing the menstrual cycle, timely ovulation and increasing endometrial thickness6.                Hence to evaluate the ovulatory properties of Rasona Ksheerapaka in anovulatory cycles this study is planned. The sample size will be divided in two equal groups, Group A will be administered with Rasona Ksheerapaka and Group B will be administered with Clomiphene Citrate.

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 35.00 Year(s)(—)
性别
Female

入选标准

  • 1 Patients of primary or secondary infertility due to anovulation or delayed ovulation 2 Patients having PCOD (Hyperandrogenic ovulatory dysfunction) 3 Irregular or scanty menses due to anovulatory cycle.

排除标准

  •  Unmarried patients non-fertile age group patients  Bleeding P/V  Carcinoma of cervix, Vaginal polypoid growth  Diagnosed patients of fibroids in uterus  Inborn genital tract abnormality  Endometritis due to tubercular infection  HIV/VDRL/HbsAg positive  Diagnosed subjects for malignancy  Patients on hormonal treatment  Non-Cooperative patients.

结局指标

主要结局

To evaluate the ovulatory effects of trial drug

时间窗: 120 days

To predict possible mode of action of trial drug on anovulatory menstrual cycle

时间窗: 120 days

次要结局

  • To provide herbal cost effective better alternative in the management of anovulation in the patients of infertility(To observe adverse drug reactions of trial drug if any during the trial & follow up period)

研究者

发起方
MGACHRC, SALOD, WARDHA
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR Varsha P Jadhao

MGACHRC, Salod, Wardha, Maharastra

研究点 (1)

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