Clinical Study to evaluate the efficacy of Ajamodadi Vati in the management of Premenstrual Syndrome

NEED FOR STUDY

Majority of women, approximately 80 - 90% experience at least one PMS symptom during their menstrual cycle, but are still able to function normally at work and at home. There is, however, evidence that women with PMS experience higher levels of daily and traumatic life stress.  This accounts for a large proportion of the world’s population and workforce.

Women experience severe symptoms that are emotionally, behaviorally and physically disabling, particularly in the area of family and personal relationships, work productivity and social activities. It can impact an individual’s interpersonal relationships, social interactions, productivity, lifestyle, school performance and emotional well-being.

This study has been designed to explore the nidanas and the various factors affecting PMS and to evaluate the efficacy of Ajamodadi Vati in its management.

OBJECTIVES

• Comprehensive study of Premenstrual Syndrome

• to perform phytochemical analysis of Ajamodadi Vati

• to evaluate the efficacy of Ajamodadi Vati in the management of Premenstrual Syndrome

REVIEW OF LITERATURE

Studies show that up to 80% of women in the reproductive age experience at least a few mild symptoms of PMS prior to menstruation. But clinically significant PMS is seen only in 3 to 8% of women. Its more severe form, Premenstrual Dysphoric Disorder (PMDD) has listed one among the Depressive mental disorders by American Psychiatric Association. Premenstrual Syndrome is an often neglected medical condition due to social taboo of not discussing menstruation. It was not considered as a disease earlier due to unawareness of the symptoms of the disease and its impact. The disease is still considered a medical mystery with unknown causes, any proven diagnosis and medication in modern medicine.

PMS is largely caused due to hormonal imbalances in the body.  Estrogen levels  fluctuate during the luteal phase and are responsible the mood changes in women. Clinical trials have shown that serotonin precursors significantly increase between days 7 - 11 and 17 - 19 of the menstrual cycle i.e corresponding to the ovulatory and luteal phases of the menstrual cycle. According to molecular biology studies, the decreased estrogen causes the hypothalamus to release norepinephrine, which triggers a decline in acetylcholine, dopamine, and serotonin that leads to insomnia, fatigue and depression. This indicates that PMS is closely associated with mood disorders through estrogen-serotonin regulation.

Currently, various medications are used for the treatment of PMS. Hormonal medications are largely used to relieve typical PMS-related symptoms. These medications suppress the production of certain hormones made naturally in the body and interfere with the menstrual cycle. Various analgesics are used in the treatment of PMS, including nonsteroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid  (Aspirin) and Ibuprofen.

NOVELTY

PMS is managed by the prescription of medications such as hormonal therapy, antidepressants, diuretics, analgesics and anti-anxiety drugs.

The most common mode of hormonal therapy to influence the menstrual cycle is by taking hormonal contraceptives, such as birth control pills. Various analgesics including nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used by women. NSAIDs reduce inflammation, relieve pain and block the production of prostaglandins. Many women who frequently suffer with back pain, a headache or abdominal cramps before getting their period,  prefer  taking these painkillers. Though NSAIDs can effectively relieve pain and are usually well tolerated, their most common side effects include stomach problems, nausea, vomiting and drowsiness.

Ajamodadi vati is a unique formulation comprising of 12 drugs, each with unique pharmacological actions. It includes herbs that are Vatagna (alleviates vata dosha), shula prashamana (analgesic), dipana (carminative),  balya(invigorator) etc. The drugs are known to have antispasmodic, anti-inflammatory and antiemetic actions amongst others. It’s unique preparation method facilitates easy palatable, making the medication a one of a kind intervention for management of Premenstrual Syndrome and its associated symptoms.

METHODOLOGY

1. MATERIALS

2. Materials required

• Consent form
• Case report form
• Menstrual Distress questionnaire
• Premenstrual Syndrome questionnaire
• Ajamodadi vati 500 mg

2. Drug review

3. Ajamoda (Carum roxburghianum Benth)

4. Shati (Hedychium spicatum Buch. Ham)

5. Shunti (Zingiber officinale)

6. Shatavari (Asparagus racemosus)

7. Nirgundi (Vitex negundo)

8. Yavani (Tachyspermum ammi)

9. Krishna jeeraka (Carum carvi)

10. Shatapushpa (Anethum graveolens)

11. Twak (Cinnamomum zeylanica)

12. Yashtimadhu (Glycyrrhiza glabra)

13. Tila taila (oil of Sesamum indicum Linn)

14. Ashwagandha (Withania somnifera Dunal)

15. METHOD OF COLLECTION OF DATA:

A group of 30 subjects fulfilling diagnostic and inclusion criteria will be selected. The detailed case proforma has been prepared for the study, with all points of history taken, signs and symptoms of Premenstrual Syndrome, normal findings of investigations, assessment parameters and intervention plan. A questionnaire on assessment of various subjective criteria and a standardized Menstrual Distress Questionnaire (MEDI-Q) will be used to assess the various symptoms, both before intervention and after intervention. Results will be drawn by scoring the tests on the basis of standard methods and will be analyzed statistically.

2.1 DIAGNOSTIC CRITERIA:

1. Marked affective lability (e.g mood swings, feeling suddenly sad or tearful, or increased sensitivity to rejection)
2. Marked irritability or anger or increased interpersonal conflicts
3. Markedly depressed mood, feelings of hopelessness, or self-deprecating thoughts
4. Marked anxiety, tension, and/or feelings of being keyed up or on edge

One (or more) of the following symptoms must additionally be present to reach a total of 5 symptoms when combined with symptoms from criterion above.

1. Decreased interest in usual activities
2. Subjective difficulty in concentration
3. Lethargy, easy fatigability, or marked lack of energy
4. Marked change in appetite; overeating or specific food cravings
5. Hypersomnia or insomnia
6. A sense of being overwhelmed or out of control
7. Physical symptoms such as breast tenderness or swelling; joint or muscle pain, a sensation of bloating or weight gain

2.2 ASSESSMENT CRITERIA:

• All the results will be analyzed statistically based on the following criteria, both before and after the intervention - depressed mood, anxiety/tension, affective lability, irritability and decreased interest.
• Associated symptoms - pain, nausea, vomiting, diarrhoea, headache, constipation, giddiness, fatigue, mood swings, change in sleeping pattern, change in appetite and productivity will be assessed separately.
• Associated symptoms : if present or absent will be assessed separately.

2.2.1 SUBJECTIVE CRITERIA :

1. Depressed Mood - Depressed mood, negative affective state, dysphoria
2. Anxiety/Tension - Tense, anxious, restless, jittery, upset, high-strung, unable to relax
3. Affective Lability - Aware of feeling moody or emotional, marked spontaneous mood swings, occasional crying, feeling of loneliness, obvious persistent moodiness
4. Irritability/Hostility - Irritable, hostile, negative attitude, critical, sarcastic, angry, short-fused, yelling and screaming at others
5. Decreased Interest - Avoidance of social activities and interactions with family, at home, at work, at school, etc.
6. Concentration Difficulties - Forgetful, poor concentration, distractible, confused, lowered judgment
7. Marked Lack of Energy - Decreased efficiency, easily fatigued
8. Eating Habits
9. Sleeping Habits
10. Overwhelming Emotions
11. Physical Symptoms
12. Miscellaneous

2.3 STUDY DESIGN:

The study will be an open label single arm interventional clinical trial.