Open randomized controlled clinical trial of Shalmali Ghrita in Raktapradara with special reference to menorrhagia
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of Shalmali Ghrita in management of Raktapradar
Study Overview
Brief Summary
An exhaustive description of gynaecological diseases is mentioned in Ayurveda. The sign and symptom of abnormal excessive vaginal bleeding is given the term Asrugdara. Asrugdara literally means Dirana (excessive release) of Asrik (menstrual blood). Another term Raktapradara is also used which signifies Pradirana (excessive discharge) of Rakta or Rajah (menstrual blood). Aacharya Charaka described Asrugdara as a separate disease along with its management in Yonivyapad Chikitsa Adhyaya.Raktapradar comprises of pradiran which means excessive menstrual blood loss and prolonged menstruation. Cyclic regular menstrual bleeding which is excessive in amount & duration and volume. considered as Menorrhagia. Raktapradar can be correlated with menorrhagia. Abnormal uterine bleeding (AUB) is a broad term that describes irregularities in the menstrual cycle involving frequency, regularity, duration, and volume The treatment protocol for Raktapradar according to Ayurveda is based on correction of pitta dosha anubandhi vata dosha along with Rakta dhatu vata dosha is root cause of all the yoni dushti.Prevalance of Abnormal Uterine Bleeding is 17.09%
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Women with age group 21 to 40 yrs.
- •2.Patient having heavy menstruation with prolonged bleeding (more than 7 days) 3.Excessive bleeding for atleast 2 consecutive cycle 4.Patient having regular menstrual cycle 5.Patient having HB more than 7gm %.
Exclusion Criteria
- •1.Pregnancy 2.Congenital anamolies of genital tract 3.Patients undergoing treatment for any other illness.
- •4.Malignancy 5.Bleeding disorders 6.Patient with IUCD or on any other hormonal therapy 7.Systemic causes-uncontrolled hypertension, diabetes 8.Infections like STD 9.Patient with uterine Fibroid of size more than 4cm and more than 3 in number.
Outcomes
Primary Outcomes
To evaluate the efficacy of Shalmali Ghrita in management of Raktapradar
Time Frame: 90 Days
Secondary Outcomes
- To review the ayurvedic concept of Raktapradar(To review the concept of)
Investigators
Dr Shital Dattrao Budhwant
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta