A Pharmaceutico-Analytical and Clinical study ofSaubhagyadi Gutika on Kashatartava w.s.r. to Dysmenorrhea

The synopsis entitled as- “A pharmaceutico-Analytical and Clinical study of Saubhagyadi Gutika on Kashtartava w.s.r. to Dysmenorrhoeaâ€

Aims and Objective of the study :-

1. To prepare Saubhagyadi Gutika and established its SMP.

2. To conduct Analytical study of Saubhagyadi Gutika.

3. To evaluate the Clinical efficacy of Saubhagyadi Gutika on Kashatartava (dysmenorrhea).

PLAN OF STUDY

Pharmaceutical study:

Sources - Collection of raw materials by genuine sources. Saubhagyadi Gutika will be prepared in the Rasa-Shala attached with PG department of Rasa-shastra & Bhaishajya Kalpana, State Ayurvedic College & Hospital Lucknow.

Contents of formulation for each batches:- Saubhagyadi Gutika is mentioned in “Rasa Tantra Sar va Siddha Prayoga Sangrahâ€. The formulation has six content Suddha Kaseesa, Shuddha Tankan, Shuddha Hingu, Yavani,Krishnamarich, Aelua(Kumari Satva) in the ratio of 1:1:1:2:3:5. Minimum three sample of Saubhagyadi Gutika will be prepared for study.

Analytical Study

In this study all the drug sample and formulation will be analyzed on this parameters.

Organoleptic analysis:- Colour, Taste, Odour, Form etc.

Physico-chemical analysis:- Hardness, Uniformity of weight, Loss on drying ,Water-soluble extract, Alcohol soluble extractives, Total Ash value ,Acid insoluble ash, TLC ,Disintegration time etc. as per availability.

Design of Clinical Study

**Sample Sources -**All the patients will be selected from the OPD and IPD of PG department of Prasuti Tantra and Stri Roga.

Type of study- Single arm open clinical trial.

Sample size- Minimum 30 patients

Duration of treatment :- 3 consecutive cycle

Follow-up:- On the clearance of next one successive menstrual cycle after completion of trial.

CRITERIA TO BE ADOPTED

Patient comes with chief complaint of pain during menses along with associated symptoms.

Inclusion Criteria

1. Patients who are suffering from primary dysmenorrhea.

2.  Patient comes with chief complaint of pain during menses along with associated symptoms.

3.  Patients within the age group 18-40 years.

4. Patients suffering for more than 3 consecutive cycles.

5. Patient with H/O using analgesics and other drug during menses.

Exclusion Criteria

1. Patients below 18 and above 40 years of age.

2. Patients suffering from secondary dysmenorrhea; having organic pathology of uterus and adenexa. e.g.-

Fibroid uterus, carcinoma of endometrium, venereal diseases, PID, adenomyosis, endometriosis etc.

3.  Patients suffering from systemic diseases.

4.  Patient using intra uterine contraceptive devices.

5.  Those under any hormonal therapy.

6.  Patients having Pain abdomen associated with excessive bleeding p/v.

7.  Patients with H/O thyroid dysfunction.

 ASSESSMENT CRITERIA

Cardinal Symptoms

Severity of pain, Duration of pain, Site of pain (lower abdomen, back, thighs & legs),Nature of pain

Associated symptoms

Praseka (Nausea),Chhardi (Vomiting),Vibandha (Constipation) ,Atisara (Diarrhea),Aruchi (Loss of appetite),Shrama (Fatigue),Shirashula (Headache),Vankshana Shula (tenesmus of the bladder), Kati Shula,and Janu Shula, Swedadikya (excessive sweating), Tamodarshana (Faints)

 CRITERIA OF ASSESSMENT:

The improvement in the patient will be assessed mainly on the basis of relief in the signs and symptoms of the disease. To assess the effect of therapy

objectively, all the signs and symptoms are given scoring depending upon their severity. Dysmenorrhoea, the cardinal symptom will be assessed on its severity

and duration of persistence. Other associated symptoms according to Ayurveda as well as per modern, will also be assessed by the scoring method.

A special SCORING PATTERN will be applied in symptoms along with Visual Analog Scale, WaLIDD SCORE.

 CRITERIA FOR WITHDRAWAL:

1. During the course of trial if any serious condition or any serious adverse effects occurs and that requires urgent treatment.

2. Subject herself wants to withdraw from the clinical trial.

3. Irregular follow-up.

 ASSESSMENT OF TOTAL EFFECT OF THERAPY:

Based on the assessment of the symptoms, the total effect of therapy is evaluated and grouped according to the following criteria.

Complete Improvement -    100 % relief in clinical symptoms

Marked Improvement -       75 - 100 % relief in clinical symptoms

Moderate Improvement -    50 - 75 % relief in clinical symptoms

Mild Improvement -            25 - 50 % relief in clinical symptoms

No improvement -                0 - 25 % relief in clinical symptoms.

 STATISTICAL ANALYSIS :- The documented observations and findings of the study will be assessed by using statistical analysis to set up the efficacy of the trial drug.