A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF HINGWADI CHURNA AND ERANDA BHRISTA HARITAKI CHURNA ALONG WITH TRIVRIT TAILA MATRA BASTI IN THE MANAGEMENT OF UDAVARTA YONI VYAPADA W.S.R TO PRIMARY DYSMENORRHEA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- NRS – Scale: Numeric Rating Scale for Dysmenorrhea
研究概览
简要总结
NEED OF THE STUDY
Udavarta Yonivyapad is one of the common Gynaecological disorders, which affects a large section of female population. Conventional allopathic medical treatment may relieve symptoms of dysmenorrhea but it does not address the root cause of the problem. In modern system of medicine dysmenorrhea is treated by hormones, non-steroidal anti-inflammatory, anti-spasmodic, analgesic drugs etc. Long term use of these drugs may cause side effects like hepatotoxicity, nephrotoxicity, headache, dizziness, vertigo, depression, skin rashes etc. So to avoid these complications, an attempt is made to find solution to address root cause of this problem. There is a great scope of research with long lasting effect, to treat the entire feature complex with single regimen and find out the treatment for the underlying pathology from Ayurveda for the management of Udavarta.
RATIONALITY OF TRIAL DRUG
The Hingwadi Churna contains Hingu, Sunthi, Maricha, Pippali, Kustha, Yava Kshara, Saindhav lavana as mentioned in Chakradutta written by Shri Chakrapani Dutt with commentary Bhavarth Sandipani by Shri Jagdishwar Prasad Trpathi, Chaukambha Sanskrit series office edition 2008, Chikitsasthan,chapter 26 on shloka Chikitsa Adhyaya , shloka no. 72 , page no. 243.Pleehashoolaapaham Rajah.
Trivrit Taila Matra basti explained by Acharya Charak in Charak Chikitsa 30 Shloka no 110 and 111.
Hingu is having Laghu, Snigdha, Tikshna Guna, Katu Rasa, katu Vipaka and Ushna Virya, Stri-Pushpa Janana, Deepana, Pachana properties.
Shunthi is Laghu and Snigdha in Guna, Katu Rasa, Madhura Vipaka and *Ushna Virya.*It has having Shula Prashamana, and Deepana properties.
Kustha is Laghu, Ruksha, Tiksna,
Yava kshara is Tikshna, Laghu, Ruksha, Sukshma, Saindhava Lavana is Laghu, Snigdha.
Matulunga is Tikshna which is used as Bhavna Dravya .
Eranda Bhrista Haritaki churna has Eranda & Haritaki as explained Erandamoola is Vrisya Vata Haranam in Charaka Sutra 25 shloka no. 40 .Haritaki which is dosha Anulomani Sarvaroga Prasamni Charaka Chikitsa 1 shloka no.32.
Pippali is Laghu,Snigdha,Tikshna in Guna, Katurasa, Madhura Vipaka and Anushna In virya.It is considered in Shula Prashamana Gana in Charak Samhita.
Maricha is Laghu,Teekshna in Guna, Katu Rasa, Madhura Vipaaka and Ushna Virya. According to Bhavaprakasha it has got Shulaprashamana and Deepana properties.
Hence it is a good combination of Shula Prashamana drugs and indicated for Anuloma Gati of Vayu. In Udavarta Urdhva Gati of Vayu is causing the pain during menses, this drug thought to be an ideal choice to explore clinically in the management of Udavarta Yonivyapad, though there is no direct indication is there for the same.
RESEARCH QUESTIONS: Is there any difference in the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yonivyapad with special reference to Primary dysmenorrhea?
HYPOTHESIS:
Null hypothesis [H0]:
There is no difference in the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yonivyapad with special reference to Primary dysmenorrhea.
Alternative Hypothesis [HA]:
There is difference in the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yonivyapad with special reference to Primary dysmenorrhea.
AIM:
To evaluate the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yoni Vyapada with special reference to Primary dysmenorrhea
OBJECTIVE:
Primary objective:
To evaluate and compare the clinical efficacy of Hingvadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yoni Vyapada with special reference to Primary dysmenorrhea.
Secondary objective:
i.To assess improvement in the quality of life.
ii.Distribution patterns in Udavarta Yoni Vyapada in different types of prakriti.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients with chief complaint of pain during menses along with associated symptoms Patients who have menstrual pain score more than grade I according to verbal multidimensional scoring system VMSS Patients who had regular menstrual cycles with normal or scanty flow of 26 to 35 days in the last 2 months Patients in age group of 18 to 30 years Patients with H/o using analgesics during menses Patient willing to give voluntary informed consent for the study.
排除标准
- •1.The patient suffering from any severe K/C/O systemic or autoimmune disorders, specially those who are mentioned as Asadhya Vyadhi as per clinical text of Ayurveda will be excluded.
- •2.Subjects having organic pathology of uterus and adnexa like Fibroid uterus, polyp.
- •3.Patients with K/C/O anatomical defects of reproductive tract, pelvic inflammatory disease, chronic leucorrhea and thyroid dysfunction, DM.
结局指标
主要结局
NRS – Scale: Numeric Rating Scale for Dysmenorrhea
时间窗: 60 days
次要结局
- 1. VMSS scale: Verbal Multidimensional Scoring System(2. Changes in Quality of life Scale for menstrual disorders)
