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Clinical Trials/CTRI/2024/06/069617
CTRI/2024/06/069617Not yet recruitingPhase 3 4

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

Parul Institute Of Ayurveda1 site in 1 country40 target enrollmentStarted: July 15, 2024Last updated:

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

Sponsor
Parul Institute Of Ayurveda
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Saniya Meer

Parul Institute Of Ayurveda

Study Sites (1)

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