CTRI/2023/08/056441Not yet recruitingPhase 2
A Randomized Open Labeled Comparative Clinical Study To Evaluate The Efficacy Of Pratimarsha Nasya With Shatapushpa Taila And Tila Taila In Artava Kshaya w.s.r. To Oligomenorrhea
Dr Netra Karjagi1 site in 1 country30 target enrollmentStarted: August 24, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement in flow of menstrual bleeding, Interval between 2 cycles
Study Overview
Brief Summary
- Streeroga includes an array of diseases, among which Artava Dushti indicates menstrual disorders. The ultimate effect of Artava Vyapath is Abeejatva, diagnosis and treatment of Artava Vyapath is essential
- Artava Kshaya is a condition in which menstruation fails to occur at appropriate time (delayed) with scanty flow and does not last for 3 days.3
- A similar entity in contemporary science, where menstrual bleeding occurring more than 35 days apart and which remains constant at the frequency is called oligomenorrhea.
- The treatment opted in modern system of medicine is hormonal therapy, which may have adverse effect on body like obesity, nausea, vomiting, endometrial cancer and breast cancer.
- Acharya says “Nasa Hi Shiraso Dwaram†i.e. Nasa is said to be the door of Shiras because Nasa is indirectly connected with the brain centers in the head.
- As Nasya helps in regulating hypothalamus where GnRH is produced and is also connected with pituitary gland which produces hormones like FSH, LH, estrogen, progesterone and prolactin thus resulting in regulation of HPO axis.
- Nasya is very convenient to the patients due to its easy procedure and less requirement of time. Hence Shatapushpa Taila and Tila Taila Nasya is expecting to benificial results in Artavakshaya and hence taken for the study.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Subjects of age group between 18 years to 40 years.
- •2.Both married and unmarried women.
- •3.Subjects presenting with classical symptoms of Artava Kshaya.
- •4.Subjects presenting with symptoms of Oligomenorrhea.
- •5.Subjects with Poly Cystic Ovaries.
Exclusion Criteria
- •1.Subjects with history of PID, Tuberculosis, Pelvic Endometriosis, Adenomyosis.
- •2.Subjects with known cases of Hypertension, Thyroid disorders, Anemia.
- •3.Subjects with any known case of Benign and Malignant tumors.
- •4.Subjects with Congenital Anomalies.
- •5.Nasya Ayogya.
Outcomes
Primary Outcomes
Improvement in flow of menstrual bleeding, Interval between 2 cycles
Time Frame: Before treatment 0th day | after treatment - after subjects gets her cycle
Secondary Outcomes
- Reduction of pain during menstruation, number of pads.(0th Day ,After subject gets her cycle (Maximum study duration 42 days))
Investigators
Study Sites (1)
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