A clinical trial to study effect ofYavani formulations on Menstrual Pain
- Conditions
- Inflammatory disease of uterus, unspecified,
- Registration Number
- CTRI/2020/10/028604
- Lead Sponsor
- Dr Mauli Vaishnav
- Brief Summary
Dysmenorrhoea is one of the most common problem in female of reproductive age. Majority of cases of dysmenorrhoea fall in to the group of primary dysmenorrhea. A systematic review of studies in developing countries found that approximate 50 % of adult women, and about 75 % of adolescents, experienced pain with menstruation, with 5 - 20 % reporting severe dysmenorrhea or pain which prevents them from participating in their usual activities. Its prevalence is higher up to 5-15% more in intelligent, sensitive and stressful working class women.Primary dysmenorrhea can be correlated with Udavartini Yonivyapada characterized by pain during menstruation. Yavani (Trachyspermum ammi) is used for dysmenorrhoea in Indian folk lore practice since long ago. Acharya Bhavamishra has mentioned Yavani as ‘shoolahrit’ by which means the property of pain reduction.Along with this background the study will be conducted to evaluate and compare effect of Yavani in different dosage forms for the management of Udavartini Yonivyapad with special reference to Primary Dysmenorrhoea.
MEthodology
· Physicochemical analysis and safety profile will be evaluated prior to clinical study as per protocol.
· A single blind comparative clinical study where minimum of 200 patients diagnosed as Udavartini Yonivyapada will be selected and categorized into 4 groups of 50 patients each.
· **Group A – Yavani Churna**
These patients will be administered with Yavani churna – 2 gm 3 times in a day orally with water.
· **Group B - Yavani Arka**
These patients will be administered with Yavani Arka -10 ml 3 times per day orally with water.
**Group C – Yavani Arka bhavita churna**
These patients will be administered with Yavani Arka bhavit Churna in capsule form-1 gm 3 times per day orally with water.
· **Group D – Control group**
These patients will be administered standard drug used for dysmenorrhea –Mefenamic acid 250 mg three times per day orally.
- All medication will be prescribed for 3 days during menstrual phase.
- Follow up treatment will be given for 2 consecutive cycles during menstrual phase in all groups.
- Total study period 5 cycle = 3 months with intervention + 2 months without intervention observation
Assessment Criteria - VAS, Intensity of Pain, Duration of pain, Intramenstrual pain, Ammount of Blood loss and associate symptoms such as nausea, vomiting, anoraxia, headache, breast pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 200
- Patients complaining painful menstruation at least two consecutive cycles.
- Patient having regular menstrual cycle.
- Acute infection, 2.
- Acyclic and excessive bleeding more than 4 pads/day or more than 5days.
- Any pelvic pathology leading to dysmenorrhoea 4.
- Intra Uterine Contraceptive Device induced painful bleeding 5.
- All secondary causes leading to dysmenorrhoea.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Various kalpana of Yavani can be 70 % effective on Udavartini Yonivyapad WSR to Primary Dysmenorrhoea. After completion of 3 cycle of menstruation and 5 cycles of menstruation | on the 4th day of menstrual cycle
- Secondary Outcome Measures
Name Time Method Various kalpana of Yavani can provide 80 % beneficial effect on in pain during menstruation and provides beneficial effect on digestive system. on 3rd day of menstrual cycle
Trial Locations
- Locations (2)
Parul Institute of Ayurved and Research
🇮🇳Vadodara, GUJARAT, India
Pinnacle Biomedical Research Institute
🇮🇳Bhopal, MADHYA PRADESH, India
Parul Institute of Ayurved and Research🇮🇳Vadodara, GUJARAT, IndiaDr Mauli VaishnavPrincipal investigator9589788336maulivaishnav@gmail.com