A Clinical Study To Assess The Effect Of Draksha Rasakriya in Premenstrual Syndrome

Phase 2

Not yet recruiting

Conditions: Other hyperfunction of pituitary gland. Ayurveda Condition: PITTAPRAKOPAH,

Registration Number: CTRI/2023/08/057152

Lead Sponsor: Dr. Shilpa Saunshimath

Brief Summary: Premenstrualsyndrome is a common cyclic and recurrent disorder in female reproductivepopulation. It is characterized by somatic and psychological symptoms thatconsistently occur during luteal phase of the menstrual cycle1. PMSis a disease where many of them are unable to differentiate it into a diseaseand procure proper care.

                     Recent studieson prevalence of PMS states that nearly 50 percent of study populationpresented symptoms of premenstrual syndrome2.Most women ofreproductive age have varying physical discomfort and psychologicaldisturbances prior to menstruation. Symptoms are often mild, but can be severeenough to substantially affect daily activities, which can affect the overallhealth of

the female.

Treatment whichare mentioned in contemporary science like Antidepressants, Diuretics,Anxiolytic drugs SSRI (Selectiveserotonin Reuptake Inhibitors, SNRI (Selective Nor adrenaline ReuptakeInhibitors), GnRH analogues, Oralcontraceptive pills,Danazol3,4,5. etc have definitely some or otherside effects in long term usage.

The luteal phase can be considered as *Rutuvyateeta Kaala*, in this period the *Pitta* is predominant6 and *Pittadushti Lakshanas* such as *Alpanidrata*(insomnia) , *Balahani* (tiredness,fatigue, restlessness), *Indriyadourbalya*( mood swings, forgetfulness, confusion, tension, irritability, depression,anxiety etc)7,8.will be seen and there is no menstrual disorderwithout involvement of *Vata* . Thereforein this condition   *Vatapittashamaka Chikista* will be the line of choice.

There is no definite treatment has been explained for PMS.Based on *Chikitsasutra* of *Yonivyapad* we need to come out withmanagement. Hence there is wide scope of research. The *Draksha* which is said to be *ShreshtaPhala* and *Vatapittashamaka9*,therefore *Draksha* in the form of *Rasakriya* selected for present study inthe management of PMS

**MATERIALS AND METHODS:**

**7.1)** **SOURCE OF DATA:**

**(a)LiterarySource** â€“ Classicaltext books of Ayurveda, text books of contemporary sciences, published articles from journals and authentic websites.

**(b)Drug source** - The Draksha will be procured fromlocal market and will be authenticated by   Department of Dravyaguna vijnana JSS Ayurveda Medical College Mysuru.

**Method of preparation:** Thepreparation will be done in JSS Ayurveda pharmacy (GMP Certified)

1part of *Draksha* soaked in 4 parts ofwater overnight. Next morning *Draksha*grinded, and

*Swarasa* is extractedout of it. Then *Swarasa* is boiledtill it attains semisolid consistency18and stored in air tightcontainer.

**(c)Samplesource** - Subjects fulfilling the criteria for diagnosis and inclusionvisiting OPD and IPD of Dept of Prasooti Tantra and Streeroga, JSS Ayurveda MedicalCollege and Hospital, Mysuru, medical camps and other referrals will be takenfor the study.

**7.2) METHOD OF COLLECTION OF DATA:**

**a. Study design:** It is an open label single arm clinical study.

**b. Sample size:** 30 subjects fulfilling the inclusion criteriaof Premenstrual syndrome will be selected for the study irrespective ofreligion, occupation and socio-economic status.

**c. Selection criteria:** The subjects whofulfill the inclusion criteria and complying with the informed consent will beselected.

**D.DIAGNOSTIC CRITERIA:** 19

       Subjects will be diagnosed basedon Diagnostic criteria proposed by ACOG

| |

| --- |

| Any one of affective symptoms and at least one of the following somatic symptom must be reported 5 days before menses and relieved within 4 days of the onset of menses without recurrence until at least 13th day of the cycle.

**Affective symptoms                                                Somatic symptoms**

1.Depression                                                           1.Breast tenderness

2.Angry outbursts                                                   2.Abdominal bloating

3.Irritability                                                            3.Headache

4.Anxiety                                                              4.Swelling of extremities

5.Confusion

6.Social withdrawl

**E.INCLUSION CRITERIA:**

Ã˜ Subjectsbetween the age group of 20-40

Ã˜ Subjects fulfilling the diagnostic criteria

**F.EXCLUSION CRITERIA:**

Ã˜ Subjectswith untreated depression or psychiatric disorder.

Ã˜ Pregnancy and Lactation

Ã˜ Diagnosedcase of metabolic disorders such as thyroid disease, diabetes mellitusâ€¦

Ã˜ Subjectswith pelvic pathology

Ã˜ Subjectsunder hormonal medications such as oral contraceptive pills.

**G.ASSESSMENT CRITERIA:**

Assessment will be done with most available measures COPE (Calendar OfPremenstrual Experience)20.

Severity of PMS symptoms will be rated by the participants on the basisof impact on their daily

gives ranging from mild to moderate to severe.

Mild â€“ Symptoms defined were not limiting daily activity.

Moderate â€“ If there is marked limitations with regard to dailyactivities.

Severe â€“ Participants were unable to carryout the activities without discomfort.

**PLAN OF TREATMENT**

The subjects willbe given with *Draksha Rasakriya* 10gmBD starting from 5th day of menstruation till the beginning of thenext menstrual cycle for 3 consecutive cycles. The signs and symptoms will beobserved before and after the treatment.

                                                                    **Intervention period:** 3 Cycles

**Follow up:** 2Cycles

**Total study duration:** 5 Cycles

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

.Subjects between the age group of 20-40 .Subjects fulfilling the diagnostic criteria.

Exclusion Criteria

.Subjects with untreated depression or psychiatric disorder.
.Pregnancy and Lactation .Diagnosed case of metabolic disorders such as thyroid disease, diabetes mellitusâ€¦ .Subjects with pelvic pathology .Subjects under hormonal medications such as oral contraceptive pills.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relieve in psychosomatic symptoms Premenstrual syndrome after 3 months of drug administration.	Outcome will assessed after study period that is \| 1st - After 12 weeks \| 2nd - After 16 weeks \| 3rd - after 20 weeks

Secondary Outcome Measures

Name	Time	Method
There is improvement in quality of life,nutrition & functioning of bowel & bladder	Outcome will be assessed after the study period that is

Trial Locations

Locations (1): Jagadguru Sri Shivaratreeshwara Ayurveda Medical College ad Hospital Mysuru.
🇮🇳
Mysore, KARNATAKA, India
Jagadguru Sri Shivaratreeshwara Ayurveda Medical College ad Hospital Mysuru.
🇮🇳Mysore, KARNATAKA, India
Dr Shilpa Saunshimath
Principal investigator
9611467449
shilpasaunshimath555@gmail.com