INTRODUCTION:

Dysmenorrhea is the most common gynecological problem faced by women during their adolescence. It causes significant discomfort and anxiety for the woman as well as her family. A systematic review of studies from developing countries revealed that about 25%–50% of adult women and about 75% of adolescents experience pain during menstruation, with 5%–20% reporting severe dysmenorrhea or pain that is severe enough to prevent them from carrying out their day-to-day activities¹. The word Kashtartava itself gives an idea of the difficulty experienced during menstruation². Kashtartava can be taken to be the same as the ‘dysmenorrhea’ of modern medicine. Primary dysmenorrhea is a condition which causes painful menstruation without any demonstrable pelvic pathology³. In addition to menstrual pain, many woman experience associated symptoms such as headache, constipation, nausea, vomiting, fatigue, and leg pains. The etiology of uterine pain in primary dysmenorrhea is still not established. But several risk factors have been identified, such as young age, early menarche, positive family history, nulliparity, stress/depression, and smoking. There are many theories regarding the pathophysiology of the condition⁴, with the prostaglandin theory being the one that is most generally accepted. The treatment usually advocated in modern medicine, i.e., analgesics, antispasmodics, and/or oral contraceptive pills⁵, does not provide a long-lasting solution and, besides, may lead to serious adverse effects. Over 25% of women experience menstrual discomfort that is resistant to treatment⁶. As yet there is no treatment regimen that can relieve the entire symptom complex of primary dysmenorrhea. Hence, there is a need to find a safe and long-lasting treatment for the condition. Kashtartava, especially when it manifests as primary dysmenorrhea, is a Vata-dominant condition and can be co-related with Udavartini yonivyapad. The treatment protocol of Udavartini yonivyapad suggests matrabasti so the study is aimed at matrabasti and development of innovative drug delivery method in the form of anal suppository. The drugs selected here are Vedanasthapana Gana dravyas which not only pacifies pain but also pacifies vitiated vaat dosha.

NEED OF WORK:

 Prevalence of dysmenorrhea is 70.2% in Indian population⁷. While comparing prevalence of dysmenorrhea from other countries, Ethiopia reported 70% dysmenorrhea wherein 28.5% had moderate to severe, Malaysia reported an incidence of 6.8% having moderate to severe pain and Jordan reported 55.8% of the subjects had moderate to severe pain. Majority of the subjects experienced pain for one or 1-2 days during menstruation. 23.2% of the dysmenorrheic girls experienced pain for 2-3 days. The most common symptom in both dysmenorrheic and non dysmenorrheic girls during the menstrual periods was tiredness and second most prevalent symptom was back pain. Females experiencing mild pain on an average absented for one and half day a month while 2.1±1.2 and 2.5±1.3 days for those who experienced moderate and severe forms of dysmenorrhea respectively

An extremely significant association was found between the severity of dysmenorrhea and limitation in working capacity of females. An inverse relationship is exhibited between severity of dysmenorrhea and percentage of females reporting unaffected working ability while a proportional increase can be seen in percentage of females reporting clear inhibition of working ability.

Studies have demonstrated that menstrual pain restricts the movement and usual activity pattern of the females. It could also be argued that the perception of uneasiness and discomfort experienced during menstruation probably limits the movements more than the experience of pain. It is a point of concern since it is an indication of discomfort and poor work efficiency of the person.

So the study is focused on Dysmenorrhoea and finding an easy, effective, safe and feasible way for its management.

RESEARCH QUESTION:

•       Is vednastapana anal suppository and vedanasthapana taila matrabasti effective in primary dysmenorrhea?

AIM: To study the efficacy of Vedanasthapana anal suppository and vedanasthapana taila matrabasti in Primary dysmenorrhea

OBJECTIVES:

1. To evaluate the efficacy of Vedanasthapana anal suppository in Primary dysmenorrhea
2. To evaluate the efficacy of Vedanasthapana taila Matrabasti in Primary dysmenorrhea
3. To evaluate the comparative efficacy of Vedanasthapana anal suppository and Vedanasthapana taila Matrabasti in Primary dysmenorrhea

PREVIOUS WORK DONE:

1.       A comparative study of Dashamoola Taila Matra Basti and Tila Taila Matra Basti in Kashtartava (dysmenorrhea) Kaumadi Karunagoda, Kamayani Shukla (Upadhyaya), Shilpa Donga, Chandrika Tanna1 , L. P. Dei Department of Stree Roga and Prasooti Tantra, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, 1 Gynaecologist and Obstetrician, Jeevan Deep Hospital, Jamnagar, India.

2.       Role of Uttara Vasti with Trivrit and Lasuna oil in the management of primary dysmenorrhea Shabnam Jahan, N. Sujatha, and Neelam

3.       Efficacy of Dasamula Taila Matrabasti in Udavartini Yonivyapad Dr. Simpy Dowarah1 , Dr. Kaushalya Khakhlary2 1 PG Scholar, Dept. of Prasuti Tantra and Stree Roga, Govt. Ayurvedic College & Hospital, Guwahati-14 2Associate Professor, Dept. of Prasuti Tantra and Stree Roga, Govt. Ayurvedic College & Hospital, Guwahati-14

HYPOTHESIS:

•       Null Hypothesis(H0): Neither Vedanasthapana anal suppository nor vedanasthapana taila matra basti is effective in Primary dysmenorrhea

•       Alternate Hypothesis(H1): Vedanasthapana anal suppository is more effective than vedanasthapana taila matra basti in Primary dysmenorrhea

•       Alternate Hypothesis(H2): Vedanasthapana taila matra basti is more effective than Vedanasthapana anal suppository in Primary dysmenorrhea

•       Alternate Hypothesis(H3): Both Vedanasthapana anal suppository and vedanasthapana taila matra basti are equally effective in Primary dysmenorrhea

METHODOLOGY:

·         STUDY DESIGN:

An open labelled, randomized, Comparative, Interventional, Prospective Clinical study.

·         SELECTION OF PATIENTS:

Minimum of 100 Patients attending the IPD & OPD of Parul Ayurved Hospital, diagnosed with primary dysmenorrhea would be enrolled in the study with prior consent.

The samples will be selected by random sampling method (Computerized Randomization). Patients will be equally divided into two trial groups, each group containing 50 patients.

·         SAMPLE SIZE CALCULATION:

The Sample size for the above said study is calculated using Standard Sample Size Formula (Cochran’s Formula):

                                            n=z²(pq)/e²

n = Sample Size

z = Standard Error associated with the chosen level of confidence (Typically 1.96)

p = Variability / Standard Deviation=Prevalence rate

q = 1-p

e = Acceptable sample error

With reference to above formula, the sample size was calculated considering 70.2% prevalence rate³⁶, 20% allowable error and 95% of confidence level.

The Obtained sample size is 40.76

Expecting a dropout rate of 25% in the number of patients to be enrolled in the study, the final sample size was fixed as 50 per group.

·         INCLUSION CRITERIA

                                i.            Patients with chief complaint of lower abdomen pain during menstruation with regular cycle (21-35 days) with VAS score more than 4.

                              ii.            Age groups between 18 to 30 years shall be selected.

                            iii.            Patients suffering from dysmenorrhea for at least 3 cycles in last 6 months.

                             iv.            Married and unmarried women will be incorporated for the study.

                               v.            Patients fit for matrabasti and suppository use.

·         EXCLUSION CRITERIA:

                                i.            Any space occupying lesion.

                              ii.            Women with Irregular menstrual cycles.

                            iii.            Secondary dysmenorrhea.

                             iv.            IUCD

                               v.            Women diagnosed with congenital anomalies of reproductive tract.

                             vi.            Systemic or metabolic disorders which can be contraindicated for matrabasti or suppository use.

·         INTERVENTION PROTOCOL:

Group A- Anal Suppository group

Preparation-Vedanasthapana gana suppository will be prepared in Pharmacy of Parul Institute of Ayurved.

Dose- 2 gm suppository will be inserted per anal for 5 days (twice day)

Time of Administration: 7 days prior to expected date of menstruation

Duration- Consecutive 2 cycles

Group B- Matrabasti group

Preparation-Vedanasthapana gana taila will be prepared in Pharmacy of Parul Institute of Ayurved. Tail will be prepared as per Snehapaak vidhi mentioned in Sharangdhar Samhita

Dose- 60 ml for 5 days (once a day)

Time of Administration: 7 days prior to expected date of menstruation

Duration- Consecutive 2 cycles

Rescue Medicine: PCM/Mefenamic acid

·         INVESTIGATIONS

Routine hematological and urinary examinations will be done before treatment. Sonography to rule out uterine and adnexal pathology will be done as per need.

·         STUDY CENTRE:

Study will be conducted at Parul Institute of Ayured(PIA), Parul Institute of Ayurved and Research (PIAR) and Parul Ayurved Hospital, Vadodara.

·         SOURCES OF DATA

a)       Literary Source-All classical, modern literature and contemporary texts including journals and websites about the disease, drugs and procedures will be reviwed and documented for the study.

b)      Pharmaceutical Source- Vedanasthapana Gana anal Suppository and Taila will be prepared in the GMP certified Pharmacy of Parul Institute of Ayurved.

c)       Clinical Source- Patients who are ready to give consent will be included from Parul Ayurved Hospital.

·         CRITERIA OF ASSESSMENT

1.      WaLIDD Score³⁹

2.      Effect on Menstrual Pain-VAS Score⁴⁰

3.      Associated Complaints score⁴¹

4.      Improvement in Quality of Life- SF-36 (RAND) questionnaire^42,43

1. WaLIDD Score: Assessment will be done on 1^st  and 5^th  day of each cycle

2. VAS Score

3. Associated Symptoms:

•      Scoring of associated Symptoms

4. Improvement in Quality of Life- SF-36 (RAND) questionnaire Score:

·         Overall effect of the intervention will be estimated in the following 5 categories:

·         STUDY DURATION: 18 months

·         ASSESSMENT AND FOLLOW UP:

Initial assessment at the time of enrolment (BT) then assessment during 1^st menstrual cycle, 2^nd menstrual cycle and follow up for next 2 consecutive cycles (AT).

WaLLID score will be assessed on first and last day of each menstrual cycle.

Assessments at intervals- 0, MC1, MC2, MC3, MC4

·         STATISTICAL ANALYSIS:

Collected data and observation will be analyzed critically and scientifically by employing statistical tests.