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CTRI Number  CTRI/2017/11/010472 [Registered on: 13/11/2017] Trial Registered Retrospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   VIJYADI VATI AND KUBERAKSHA VATI IN KRICCHARTAVA (DYSMENORRHOEA) 
Scientific Title of Study   A Comparative Clinical Study of Vijayadi Vati and Kuberaksha Vati in the Management of Kashtartava With Special Reference to Primary Dysmenorrhoea. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Sharma 
Designation  Ph. D. Scholar  
Affiliation  National Institute of Ayurveda 
Address  P.g. Deptt. of Prasuti and street toga, National Institute of ayurveda, Joraver singh gate, Amer Road , Jaipur
Girls Hostel, National institute of Ayurveda, Jaipur-302002
Jaipur
RAJASTHAN
302002
India 
Phone  8988005960  
Fax    
Email  ps.17julyacad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Sharma 
Designation  Ph. D. Scholar (Student) 
Affiliation  National Institute of Ayurveda 
Address  P.g. Deptt. of Prasuti and street toga, National Institute of ayurveda, Joraver singh gate, Amer Road , Jaipur
Girls Hostel, National institute of Ayurveda, Jaipur-302002
Jaipur
RAJASTHAN
302002
India 
Phone  8988005960  
Fax    
Email  ps.17julyacad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Sharma 
Designation  Ph. D. Scholar (Student) 
Affiliation  National Institute of Ayurveda 
Address  P.g. Deptt. of Prasuti and street toga, National Institute of ayurveda, Joraver singh gate, Amer Road , Jaipur
Girls Hostel, National institute of Ayurveda, Jaipur-302002
Jaipur
RAJASTHAN
302002
India 
Phone  8988005960  
Fax    
Email  ps.17julyacad@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Amer Road, Near Zoraver Singh Gate, Jaipur, Rajasthan, 302002 
Type of Sponsor  Other [Goverment Ayurveda College and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Sharma  National institute of Ayurveda  National Institute of Ayurveda Hospital Opd no 26 and 27 Prasuti Dept Jaipur,
Jaipur
RAJASTHAN 
8988005960

ps.17julyacad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kuberaksha Vati  Group B: Minimum 50 patients of Kashatartava will be treated by Kuberaksha Vati orally. Dose - 500mg twice a day with lukewarm water. Duration - Drug will be started 5 days before the due date of menses and continued for 60 days thereafter.  
Intervention  Vijayadi Vati  Group A: Minimum 50 patients of Kashatartava will be treated by Vijayadi Vati orally. Dose - 500mg twice a day with lukewarm water. Duration - Drug will be started 5 days before the due date of menses and continued for 60 days thereafter.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1. Patient coming with chief complaint of dysmenorrhoea with scanty or average
amount of menses.
2. Patient in age group of 16 to 30 years.
3. Patient having H/O dysmenorrhoea along with or without associated symptoms. 4. Patient suffering from dysmenorrhoea since more than 2 consecutive cycles.
 
 
ExclusionCriteria 
Details  1. Patient having any organic pathology of uterus and adnexae.
2. HIV, VDRL, HBsAg positive patient.
3. Patient suffering from systemic diseases.
4. Patient with Intra uterine contraceptive devices.
5. Patient with menorrhagia and metrorrhagia.
6. Patient having menstrual period interval less than 21 days or more than 35 days.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain assessment on Visual Analog Scale
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  
Outcome  TimePoints 
nausea, vomiting, giddiness, constipation, breast tenderness, diarrhea, headache, fainting   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.
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/09/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/05/2018 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

 Introduction-

Introduction is the preface of the dissertation 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, need of present research work, aims and objectives, material and method and fundamentals of selection of trial drugs and study design. According to ayurveda view, ārtava or menstruation should not be associated with any sort of discomforts as pain, burning sensation etc. There is no description of Krichārtava as a disease in Ayurveda classics. The present study is aimed at understanding Kashtartva as disease and finding out  the treatment.

 Conceptual Study

The conceptual study is further subdivided into 3 parts

 Historical Review

It covered all the relevant information from ancient classics to latest treatises which was searched, compiled systematically. The references of the disease and drug in the ancient & modern literature are described here.

 

 Disease Review

Under this section description of Disease according to Ayurveda (Kashtartava) and Modern point 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 as disease in the form of Roga Paá¹…cak i.e. Nidāna, Samprāpti, PÅ«rvarupa, Rupa, UpaÅ›aya is done.

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

 Ayurveda Review

Modern Review

 Drug Review

In drug review, detailed description of Vijyādi Vati and Kuberākṣa Vati, which include the entire description about the ingredients of formulations, including their name, synonyms, family, chemical composition, pharmaco-dynamics & pharmacological properties including modern researches related to Dysmenorrhoea. In this chapter pharmacodynamics of drugs, method of preparation and analytical study also has been discussed. 


  Pharmacognostical Study

The main aim of Pharmacognostical study was to identify dry samples of ingredients of Vijyādi Vati and Kuberākṣa Vati macroscopically & microscopically. Pharmacognostical study has been carried out in two steps; Organoleptic Study and Powder microscopy.

 Preparation of Drug

  Analytical Study


Organoleptic and physico-chemical parameters, Qualitative tests for various functional groups, thin layer chromatography were done and the data are summarized in this section.

  Clinical Study


Vijyādi Vati and Kuberākṣa Vati were evaluated for their comparative efficacy in patients suffering Kaśtārtava. The study was a randomized prospective longitudinal comparative clinical study in which clinical features of selected patients were assessed before and after the intervention.

This section comprises of:

 Material and Methods

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

 Observations

 It comprises the clinical data with observation. Assessment was done on the basis of a specially designed performa for that purpose. This chapter contains the incidence of various factors observed in the study.

·             Maximum 98 patients were Yuvati

·             Maximum 49 patients were having Abdomen pain, backache and radiating to thigh.

·             Maximum 54 patients were having spasmodic type of pain.

·             Maximum 52 patients were having onset of pain during menses.

·             Maximum 47 patients were having pain for >1-3 days in each cycle.

·             Maximum 30 patients were having heavy work as aggravating factor for pain.

·             Maximum 47 patients were having H/O taking oral medicines.

·             36 patients were having associated symptoms of grade 3 (7-10 symptoms), 31 patients were of grade 2 (4-6 symptoms), 30 patients were of grade1(1-3symptoms). 3 patients have no associated symptoms.

Result

This section has result from the clinical study were analyzed statistically to evaluate & compare the efficacy of drug. It was found that Average percentage of relief was higher in ‘Group A’ i.e. 73.7%, followed by ‘Group B’ i.e. 59.39%. It shows that effect of therapy was better in Group A in comparison to Group B.

15.4 Discussion


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

 Conclusion

In conclusion possible concluding views and comments are presented.Vijayādi Vaṭi was found to 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 where as Kuberākṣha Vaṭi showed better cure in symptoms which are Menstrual Flow Amount, Menstrual Flow duration. Statistically there was not much difference in between the results of two groups. Intergroup comparison of improvement of symptoms was statistically significant (p<0.05) in case of Pain duration, Pain Nature, Pain Assessment and Fatigue.


 
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