VIJYADI VATI AND KUBERAKSHA VATI IN KRICCHARTAVA (DYSMENORRHOEA)

Phase 4

Completed

• Conditions: chief complaint of dysmenorrhoea with scanty or average amount of menses, along with or without associated symptoms and dysmenorrhoea since more than 2 consecutive cycles.

• Registration Number: CTRI/2017/11/010472
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

Introduction-Introduction is the preface of thedissertation which deals with the introduction of *Kashatartava* (Dysmenorrhea) . It also includes Epidemiology,Importance of present study, Introduction of drug,  list of previous work on present topic, needof present research work, aims and objectives, material and method andfundamentals of selection of trial drugs and study design. According toayurveda view, *Ärtava* or menstruationshould not be associated with any sort of discomforts as pain, burningsensation etc. There is no description of *KrichÄrtava*as a disease in Ayurveda classics. The present study is aimed at understandingKashtartva as disease and finding out the treatment.

 ConceptualStudyThe conceptual study is furthersubdivided into 3 parts

 HistoricalReviewIt covered all the relevant information fromancient classics to latest treatises which was searched, compiledsystematically. Thereferences of the disease and drug in the ancient & modern literature aredescribed here.

  Disease ReviewUnder this section description of Disease according toAyurveda (*Kashtartava)* and Modernpoint of view (Dysmenorrhoea) has been given. It describes about the Pain during menstruation in different yonivyapads,artava dusti and other gynaecological disorders. Description of kashtartva asdisease in the form of Roga Paá¹…cak i.e. NidÄna, SamprÄpti, PÅ«rvarupa, Rupa,UpaÅ›aya is done.

Modern perspective of dysmenorrhoea includingEtio-Pathogenesis, Correlation, Types, Symptoms & Signs, Treatment,Complication and pathways of uterine pain have been described.

 Ayurveda ReviewModern Review DrugReviewIn drug review, detailed description of *VijyÄdi Vati* and *KuberÄká¹£a Vati*, which include the entire description about theingredients of formulations, including their name, synonyms, family, chemicalcomposition, pharmaco-dynamics & pharmacological properties includingmodern researches related to Dysmenorrhoea. In this chapter pharmacodynamics ofdrugs, method of preparation and analytical study also has been discussed. 


  Pharmacognostical Study The main aim ofPharmacognostical study was to identify dry samples of ingredients of *VijyÄdi Vati* and*KuberÄká¹£a Vati* macroscopically& microscopically. Pharmacognostical study has been carried out in twosteps; Organoleptic Study and Powder microscopy.

 Preparation of Drug  Analytical Study
Organoleptic and physico-chemical parameters,Qualitative tests for various functional groups, thin layer chromatography weredone and the data are summarized in this section.

  Clinical Study
*VijyÄdiVati* and *KuberÄká¹£aVat*i were evaluated for their comparative efficacy in patients sufferingKaÅ›tÄrtava. The study was a randomized prospective longitudinal comparativeclinical study in which clinical features of selected patients were assessedbefore and after the intervention.

This section comprises of:

 Materialand MethodsThis Chapter contains detailed description of Aims &Objects, criteria of selection of patients, Grouping, Criteria for assessmentand method of evaluation of clinical recovery and Management.

 ObservationsItcomprises the clinical data with observation. Assessment was done on the basisof a specially designed performa for that purpose. This chapter contains theincidence of various factors observed in the study.

·            Maximum98 patients were Yuvati

·            Maximum49 patients were having Abdomen pain, backache and radiating to thigh.

·            Maximum54 patients were having spasmodic type of pain.

·            Maximum52 patients were having onset of pain during menses.

·            Maximum47 patients were having pain for >1-3 days in each cycle.

·            Maximum30 patients were having heavy work as aggravating factor for pain.

·            Maximum47 patients were having H/O taking oral medicines.

·            36patients were having associated symptoms of grade 3 (7-10 symptoms), 31patients were of grade 2 (4-6 symptoms), 30 patients were ofgrade1(1-3symptoms). 3 patients have no associated symptoms.

Result

This section has result from the clinical studywere analyzed statistically to evaluate & compare the efficacy of drug. It was found that Average percentage of relief washigher in **‘Group A’ i.e. 73.7%,** followedby **‘Group B’ i.e. 59.39%**. **It shows that effect of therapy was betterin Group A in comparison to Group B.**

15.4 Discussion
This section includes the discussion on conceptual review, drugreview, Clinical data obtained from the studies. Here critical discussion on minute details of disease, drug formulations, logical and scientific interpretation of dataobtained during the study and analysis of results have been discussed.

 ConclusionIn conclusion possible concluding views andcomments are presented.VijayÄdi Vaá¹­i was foundto be more effective on Symptoms which are Pain Intensity, Pain Duration,Nature, Pain Assessment, Nausea, Vomiting, Fatigue, Head ache, Fainting,Giddiness, Diarrhoea, Constipation, Vaginal Discharge, Breast Tenderness whereas KuberÄká¹£ha Vaá¹­i showed better cure in symptoms which are Menstrual FlowAmount, Menstrual Flow duration. Statistically there was not much difference inbetween the results of two groups. Intergroup comparison of improvement ofsymptoms was statistically significant (p<0.05) in case of Pain duration,Pain Nature, Pain Assessment and Fatigue.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-21
• Study Completion: 2018-07-05
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patient coming with chief complaint of dysmenorrhoea with scanty or average amount of menses.
• Patient in age group of 16 to 30 years.
• Patient having H/O dysmenorrhoea along with or without associated symptoms.

Exclusion Criteria

• Patient having any organic pathology of uterus and adnexae.
• HIV, VDRL, HBsAg positive patient.
• Patient suffering from systemic diseases.
• Patient with Intra uterine contraceptive devices.
• Patient with menorrhagia and metrorrhagia.
• Patient having menstrual period interval less than 21 days or more than 35 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessment on Visual Analog Scale	1. First follow up is done during trial after Second menses. | 2.Final outcome is assessed after completion of trial in the next consecutive menses.
Numeric Rating Scale	1. First follow up is done during trial after Second menses. | 2.Final outcome is assessed after completion of trial in the next consecutive menses.

Secondary Outcome Measures

Name	Time	Method
nausea, vomiting, giddiness, constipation, breast tenderness, diarrhea, headache, fainting	1. First follow up is done during trial after Second menses.

Trial Locations

Locations (1)

National institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Priyanka Sharma

Principal investigator

8988005960

ps.17julyacad@gmail.com