Medicated Gruel made from rice (Yavagu) in Painful menstruation.
- Conditions
- Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI,
- Registration Number
- CTRI/2024/03/064743
- Lead Sponsor
- Government Ayurved College and Hospital
- Brief Summary
Screening of patients will be done after the institutional ethics clearance of Government Ayurved College, Nagpur.
Udavartini Yonivyapad (Dysmenorrhoea)-affected patients will be screened via pre-assessment criteria based on general signs and symptoms of Udavartini Yonivyapad (Dysmenorrhoea).
In the clinical study, 40 patients with *Udavartini Yonivyapad* (dysmenorrhoea) will be included. Assessment of pain will be done according to a multi-dimensional scoring pattern and the VAS scale of pain assessment.
During the informed consent process, the subjects were given enough time to read the patient information sheet and consent form.
Subjects will also be given the freedom to ask questions, and all the questions will be answered. If she agrees to participate in the study and is found fit to be included during screening, then she will be recruited for the study. If all inclusion criteria are yes and all exclusion criteria are no, then subjects will be included on the basis of the criteria given.
Background:
Ayurveda is a health science. It’s purpose is to maintain the health of healthy individual and cure the disease of a patient. In Ayurvedic text all Dravya’s are classified into two categories – ‘Aushadha’ and ‘Ahara’. ‘Ahara’ is used for treatment of disease and also for maintaining health. In Ayurveda, ‘Ahara’ (food items) which are used for treatment are named as ‘Pathya Kalpana’. Yavagu is one of the Pathya Kalpana, prepared from basic ingredient – Rice which is easy to digest. Yavagu is Laghu, Agnidipak and gives Anuloman Gati to Vata, Mutra and Purish. In Ayurveda, Acharya Charak has mentioned “Vinshati Yonivyapad†in Chikitsasthan, which reveals most of the gynaecological disorders. Udavartini Yonivyapad is a disease mentioned by Acharya Charak under Vinshati Yonivyapad. Udavartini Yonivyapad is a Vata predominance disease. There is a derangement of Apana Vayu, as it plays a vital role in maintaining the normal function of ‘Raja’ which further leads to Udavartini Yonivyapad, where painful onset of menstruation is relieved after flow. Udavartini Yonivyapad is compared to dysmenorrhea in modern perspective. Dysmenorrhoea means painful menstruation of sufficient magnitude so as to incapacitate day to day activities. The incidence of primary dysmenorrhea of sufficient magnitude with incapacitation is about 15–20 percent. It occurs mainly in young age. It is also more common in women who never had children. The considerable high prevalence of dysmenorrhoea among adolescents verified that this condition is a significant public health problem that requires great attention. In Udavartini Yonivyapad due to forceful evacuation & controlling natural urges, Vata goes in upward direction which leads to painful menstruation. Vatanulomini Yavagu can be used as therapeutic nutrition to treat Udavartini Yonivyapad by giving Vata it’s proper direction. Vatanulomini Yavagu is one of the twenty-eight Yavagu’s mentioned by Acharya Charak in Sutrasthan. This study is carried out with the aim to study the efficacy of Vatanulomini Yavagu in the patients suffering from Udavartini Yonivyapad.
**Purpose of Trial:**
Menstruation is important from reproduction point of view and also for the general health of women. Any abnormality related to menstruation can affect her general health and bring difficulty in achieving her goals. In Udavartini Yonivyapad there is painful menstruation which disturb her daily routine activities. In modern science analgesics, antispasmodic and surgery are few options for its treatment, but they cause various side effect. However, Vatanulomini Yavagu is one of the Pathya Kalpana having no side effect and it is helpful to give Vata it’s proper direction.
Aim: To evaluate efficacy of Vatanulomini Yavagu in Udavartini Yonivyapad.
**Medium of Dissertation**: The Dissertation will be written in English by using Ayurvedic terminology wherever necessary in Sanskrit.
**Type of Study**: Open clinical trial with single arm.
**Ethical Clearance**: Clearance from IEC of our institute.
**Location of study**: Research institute, Hospital and periphery.
**Duration of study**: study will be carried out for 18 months after approval of synopsis.
**Study design**:
Review of literature & Selection of topic
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Synopsis writing & Institutional Ethics committee approval.
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Synopsis submission & approval
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Identifying raw drug & their authentication
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Packaging & Standerdization of Yavagu sachets.
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Selection of patient as per inclusion & exclusion criteria.
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Informed & written consent will be taken.
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Detailed CRF will be taken & patient will be informed about the dose, time & training of preparation of Vatanulomini Yavagu.
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Follow up of patient on 5th day of menses.
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Observation, data collection & statistical evaluation.
Discussion & Conclusion
**Duration of treatment**: Vatanulomini Yavagu will be given for 7 days before menstrual cycle for 3 consecutive cycles.
**Drug**- Medicated Yavagu of Haritaki, Pippalimula and Vishwabheshaja.
**Preparation of Drug**:
Step 1- In first step medicated water is prepared with Abhaya(3gm), Pippalimula(3gm), Vishwabheshaja (3gm) in 576 ml water. That is 1:64 proportion (As per Chakrapani tika)
Step 2- Then Yavagu is made with this medicated water. Yavagu is prepared with six part of medicated water and one part of coarse powdered rice. Then it is boiled on mild fire till the rice is cooked and a little amount of water is allowed to remain in the final recipe. The additives (i.e Salt ) can be added according to taste before serving. Patient were advised to consume this Yavagu lukewarm.
**Dose** – 50 gm (at evening diet)
**Duration of treatment on single volunteer**:
Vatanulomini Yavagu will be given for seven days before the first day of menstrual cycle for three consecutive cycles.
**Follow up**: on 5th day of menses of each menstrual cycle for 3 consecutive cycles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 40
- 1)Unmarried Patients having age between 18 to 30 years 2)Patient fulfilling diagnostic criteria- patient complaining of Udavartini Yonivyapad (Dysmenorrhoea) 3)Patients suffering from painful menstruation for more than 2 consecutive cycles.
- 4)Patients who gives written consent.
- 5)Co-operative Patients.
- 1)Patients of age less than 18 and greater than 30 years.
- 2)Married patients 3)Patients already diagnosed with or having any history of other systemic diseases that may interfere with the course of Treatment 4)Patients taking hormonal therapy.
- 5)Patients having congenital anomaly of reproductive track.
- 6)Patients with any identifiable pelvic pathology.
- 7)Patient having irregular menses & PCOS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the efficacy of Vatanulomini Yavagu in Udavartini Yonivyapad (Dysmenorrhoea) in 3 months 3 months
- Secondary Outcome Measures
Name Time Method 1. To study Agnidipak property of Yavagu. 2. To study Udavartini Yonivyapad in details.
Trial Locations
- Locations (1)
Government Ayurved College and Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital, Nagpur🇮🇳Nagpur, MAHARASHTRA, IndiaVarsharani Dilip JatharPrincipal investigator8600581361jathar2017@gmail.com