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临床试验/CTRI/2024/06/068484
CTRI/2024/06/068484尚未招募1/2 期

A Randomized Controlled Comparative Clinical Study to Evaluate the Efficacy of Guduchyadi Churna over Gokshuradi Churna in Ksheena Shukra (Oligoasthenozoospermia)

DR SHOAIB AHMED F1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To compare the efficacy of Gokshuradi churna and Guduchyadi churna in Ksheena shukra (Oligoasthenozoospermia).

研究概览

简要总结

Ayurveda entitled as a “Divine science” due to its origin as well as its unimaginable potency in curing the diseases and protecting the health of a healthy person, physically and mentally. In Ayurvedic classics, Acharyas mentioned about four Purushaarthaas i.e. Dharma, Artha, Kaama and Moksha. Kaama, the desire is also related with sexual gratification, which is one of the happiness in the life and to create a healthy progeny. The essential factors of conception are Ritu (reproductive age and ovulation period), Kshetra (female reproductive tract), Ambu (nutritional factors) and Beeja (sperm and ovum) 1. Any malfunction of these factors may lead to infertility. Acharya Charaka compares the man who is incapable of procreation as shadow less, single branched, foul smelling tree devoid of fruits that has no purpose or plays no role in the world2.

The ambition or aim of a person is that to propagate his legacy through his progeny. Infertility makes the man incapable for this. Ayurvedic classics have mentioned that the function of Shukra Dhaatu is reproduction3. There are eight types of Shukradusti according to classics4. A person having Shukradusti is unable to fulfil his Chaturvidha Purushaartha. Ksheena Shukra is one type of Shukradusti. It is Vata Pittaja Vyadhi, manifested as a result of Shukravaha Srotodusti and prevalence will be in Madhyama Vayas, being a disease from Apaana Vata province, in which decreased quality and quantity of Shukra Dhaatu is observed, which incapacitates him from conceiving his life partner, ending in Infertility.

Infertility is defined as a failure to conceive within one or more years of unprotected coitus5. Oligoasthenozoospermia is one among the prime factor in the male infertility and it is defined as a subnormal concentration of spermatozoa in the penile ejaculate with decreased sperm motility6. According to WHO guidelines on semen analysis, Oligoasthenozoospermia is the condition where the sperm concentration is less than 15 millions/milliliter7 with 40% of total sperm motility and 32% progressively motile sperm in the ejaculate. The condition Oligoasthenozoospermia can be well matched with Ksheena Shukrain Ayurveda.

Shukra Dhaatu is quantitatively and qualitatively vitiates in Ksheena Shukra and in Oligoasthenozoospermia there is quantitative reduction of sperms. According to Acharya Charaka, Ksheena Shukra and Shukra Kshaya are one and the same whereas according to Acharya Sushrutha and Acharya Vaagbhata, it is one among the Shukra Dushti in which Vata and Pitta are Vitiated8. Ativyavaaya, Ati Ruksha-Laghu-Ushna Aahaaras, Chinta, Shoka etc are considered as the Nidaanas9,10,11,12 and Dourbalya, Mukhasosha, Paandutwa, Sadana, Shrama, Maithuna ashakti etc, are the Lakshanaas of Ksheena Shukra13,14.

Infertility is global problem in the field of reproductive health. It is considered as a social stigma in India which ultimately affects the psychological harmony of the family, disturbed sexual and social life. ‘The incidence of infertility varies in different regions nearly 8-12% of couples worldwide. Of all infertility cases, approximately 40-50% is due to ‘male factor’ infertility and as many as 2% of all men will exhibit suboptimal sperm parameters. It may be one or a combination of low sperm concentration, poor sperm motility or abnormal morphology.15

As the sperm count decreases, there is corresponding decrease in likelihood of conception. Modern medical science has reached to its peak in MART (Medically Assisted Reproductive Technology), artificial insemination, invitro-fertilization, and intra-cytoplasmic sperm injection. These are considered as advanced technologies, but not accepted widely in India where poverty is rampant. So it is unable to provide service to all class of people in society, also it is not successful in even if infertile couple, they try again and again i.e. low success rate is the main fact. Ayurveda, the holistic medicine describes potent drugs and efficient therapeutic procedures to face the problem of infertility. Vajikarana, the eighth branch of Ayurveda mainly deals with the drugs and therapeutics which are aphrodisiacs in nature. It provides progeny to infertile couple, potency to the impotent, at the same time excellence of progeny with suitable therapeutic measures.Although a number of research studies have been carried out, by keeping prevalence of the disease in view, to find an effective and safe formulation for the management of Ksheena Shukra (Oligoasthenozoospermia), this research work has been undertaken, which is entitled as “A Randomized Controlled Comparative Clinical Study to evaluate the efficacy of Guduchyadi Churna over Gokshuradi Churna in Ksheena Shukra (Oligoasthenozoospermia).

The inspiration behind to take an herbal formulation “Gokshuradi Churna”16 mentioned in Chakradatta, Vrishyaadhikara(67th Chapter) for the clinical study is based on the hypothesis that its ingredients Gokshura, Ikshuraka (Kokilaaksha), Shataavari, Vaanari (Kapikachu), Naagabala and Atibala having Vrishya property,  and “ Guduchyadi Churna”17 mentioned in Harita samhita, 27th Chapter, Vajikarana adhyaya  ingredients Guduchi, Sathavari, swayangupta, Bala , Shalmali , Musali Mula  it may be useful for combating the Ksheena Shukra. The Anupana is Goksheera (cow’s milk) which is considered as Sadyovrishya and this Anupaana may be enhancing the properties of the drugs in the formula ‘Gokshuraadi Churna’ & ‘Guduchyadhi Churna’ along with its own action.

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
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Male

入选标准

  • Male Subjects of age ranging from 21 to 45 years.
  • Subjects diagnosed as Ksheena Shukra on Cardinal symptoms like Dourbalya, Sadana, Mukhashosha, Maithuna Ashakti, Medra Vedana etc.
  • Subjects with oligoasthenozoospermia, i.e. sperm count / concentration less than 15 million / milliliter with Total sperm motility 40% and sperm progressive motility 32%.

排除标准

  • Known cases of genetic abnormalities and congenital Oligoasthenozoospermia.
  • Subjects associated with systemic disorders like Diabetes, Hypertension, TB and HIV.
  • Subjects having Sexually transmitted diseases.
  • Post traumatic Oligoasthenozoospermia.
  • Subjects diagnosed as Azoospermia, Teratoazoospemia.

结局指标

主要结局

To compare the efficacy of Gokshuradi churna and Guduchyadi churna in Ksheena shukra (Oligoasthenozoospermia).

时间窗: 92 Days

次要结局

  • Tp assess the efficacy of Gokshuradi churna and Guduchyadi churna in Ksheena shukra (Oligoasthenozoospermia).(92 days)

研究者

发起方
DR SHOAIB AHMED F
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR SHOAIB AHMED F

Atreya Ayurvedic Medical College Hospital & Research Centre

研究点 (1)

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