A Comparative Clinical Study To Evaluate The Efficacy Of Shatpushpa Taila Nasya And Shatpushpa Taila Nasya Along With Shatpushpa Churna Orally In Artavkshaya W.S.R To Oligomenorrhea And Hypomenorrhea
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Duration, amount, regularity of menses
Study Overview
Brief Summary
Aim : To evaluate the efficacy of shatpushpa taila nasya along with Shatpushpa churna orally in Artavkshaya Objectives: To study artavakshaya in detail along with its possible modern correlations To establish an ayurvedic medication as a remedy for artavakshaya. To compare the efficacy of shatpushpa taila nasya and shatpushpataila nasya along with shatpushpa choorna in Artavkshay
Hypothesis :
Null hypothesis (H0) : Shatpushpa taila Nasya along with shatpushpa choorna is not as effective as shatpushpa taila nasya in the management of artakshaya .
Alternative Hypothesis- (H1) Shatpushpa taila Nasya along with shatpushpa choorna is as effective as Shatpushpa taila nasya in Artavkshaya .
Assesment criteria
subjective criteria .
a) Duration of Menstrual bleeding**:**3-5 DAYS (normal duration)-0 ,2 DAYS (moderately short duration)-1 ,1 DAYS (short duration)-2, Spotting (very short duration)-3
b) Interval between two menstrual cycle : 24-34 DAYS -score 0, 35-39 DAYS- score 1 ,40-45 DAYS score-2, ABOVE 45 score- 3
c) Quantity of bleeding or Using number of Pad /Day during Period: >2 Pad/day-0 ,2 Pad/day-1 ,1 Pad/day-2 , Spotting-3
d) Pain during Menstrual bleeding (Pelvic Pain**)**No pain-0, Mild (Able to do daily activity) -1,Moderate (Daily activities affected, need to take analgesics) -2 ,Severe (Daily activities affected ,pain continuous after taking analgesics) - 3
e) Pattern of Menstrual cycle (Regular/Irregular)Regular cycle-0, Irregular cyclep-1.
f) Bleeding /Spotting between periods : Absent- 0, Present-1
g) Consistency of Menstrual bleeding :Thin-0, Mucoid -1, Mucoid with clots -2 ,Clots -3
h) Color of Bleeding/*Srava :*Shuddha Rakta Srava - 0, Arun,KrishnaSrava (Vatajadushti) or -Neela,PittaSrava (Pittajadushti) or**Shukla, PchhilaSrava (Kaphajadushti) - 1
i) BackacheNo pain - 0 , Mild (Able to do daily activity) - 1 ,Moderate (Daily activities affected, need to take analgesics) -2, Severe (Daily activities affected,pain continuous after taking analgesics) - 3
Objective parameters BMI Underweight <18.5 kg/m 2 - 0, Normal weight 18.5-24.9 kg/m 2 -1, Overweight 25-29.9 kg/m 2 -2, Obese ≥ 30 kg/m 2 - 3
Intervention
| Group |
Group- A (Control Group of 20 Patients)
Group-B (Trial Group of 20 Patients)
|Drug
Shatpushpa taila nasya
Shatpushpa taila nasya along with shatpyshpa choorna orally
|Route
Nasal route
Nasal and orally
|Dose
2 drops in each nostril, 7 days before LMP
Nasya :-2 drops in each nostril, 7 days before LMP
Choorna :- 3 gm BD with luke warm water
|Duration
For 2 consecutive cycle
For 2 consecutive cycle
|Follow up
After completion of each menstruation for 2 Consecutive Cycle
After completion of each menstruation for 2 Consecutive Cycle
|Final followup
In 3rd month (without medicine )
In 3rd month (without medicine)
Study durationTotal 3 months (2 months for treatment & after 1 month final follow up)
Follow upFollowup during treatment : Each menstrual cycle for 2 consecutive cycle Final follow up : on 3rdmenstrual cycle
Laboratory Investigations 1)CBC 2)U.S.G (PELVIS)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 15.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Age Between 15-35 Years Irrespective Of Marital Status Symptoms of Artavkshay- yathochitkaladarshana(oligomenorrhea),artavalpata(hypomenorrhea), yonivedana (any of two) Menses for 2 days or less, 1to 2 pad per day or spottimg menses Menstrual cycle of 28 to 45 cycle Patient is willing to take part in study and ready to give consent for study.
Exclusion Criteria
- •Peri Menopause and Post Menopause Women Patients on OCPs Patients with IUCDs. Patients with knowing case of Thyroid Dysfunction, DM, uncontrolled HTN, Severe Anemia (8mg/DL) Asthma, Tuberculosis, Congenital Abnormalities of Reproductive System, Chronic Psychosomatic disorder.
Outcomes
Primary Outcomes
Duration, amount, regularity of menses
Time Frame: after each menstrual cycle for 3 consecutive cycle
Secondary Outcomes
- changes in Body mass index(after each menstrual cycle for 3 consecutive cycle)
Investigators
Dr Saniya Meer
Parul Institute Of Ayurveda
