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Clinical Trials/CTRI/2023/10/058399
CTRI/2023/10/058399Not yet recruitingPhase 3 4

EVALUATION OF EFFICACY OF KANYALOHADI VATI IN UDAVARTINI YONIVYAPATH VIS A VIS TO PRIMARY DYSMENORRHOEA -AN OPEN LABEL SINGLE ARM CLINICAL STUDY

Dr Sonal Singh1 site in 1 country30 target enrollmentStarted: October 20, 2023Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
this study is done for symptomatic management of pain in primary dysmenorrhea with ayurvedic tablet kanyalohadi vati

Study Overview

Brief Summary

•      As  per Ayurveda  predominant factor for dysmenorrhoea  is Vata.  Apanavata is  the  governing force  of  menstruation.  Its  vitiation  gives  rise  to   diseases under the entity of   yonivyapada’s Udavartini is  one  among them, where   vitiated Vata  moves  in  pratiloma gati leading to ‘painful menstruation’.  The  treatment   indicated is  normalization  of Vata.[1]

•        As dysmenorrhoea  is  one  of  the  most  common complaints amongst adolescents, it affects the quality of life  of  many  women  in  their  reproductive  age , Because  of  sedentary  life  style and  food  habits  this  problem  is increasing  day  by  day worldwide.  About 25-50%  of  adult  women  and  about  75%  of  adolescents experience  pain  during  menstruation,  with  5  -20% reporting  severe  dysmenorrhea  [2]. Dysmenorrhoea can also be associated with nausea, vomiting, diarrhea, fatigue,  which  disturbs  routine  activities . Dysmenorrhoea   is   the  leading  cause of short term school  absenteeism.  It  is associated  with  a  negative impact on social, academic and sports activities of many female adolescent [3].

•      As in cases of udavartini yoni vyapatha, vataprakopa is the main cause, the treatment should be directed to treat the vitiated  vata and to eradicate  the cause ,hence an attempt is made to treat with vatahara, vataanuloma and vedanasthapana dravyas .

As the drug which is used is palatable, cost effective and can be taken easily with busy schedule and will impact effective cure without any inconvenience .

Study Design

Study Type
Interventional
Allocation
Other
Masking
Open Label

Eligibility Criteria

Ages
16.00 Year(s) to 32.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Age group 16-32 years -patient with regular cycles complaining of painful menstruation for at least three consecutive cycles.

Exclusion Criteria

  • Pelvic pathology – Known case of Fibroid, Adenomyosis, Endometriosis, PID, Menorrhagia, Malignancy.
  • Patients with intrauterine contraceptive devices or on contraceptive pills.
  • Congenital anomalies of reproductive system.
  • Metabolic disorders – known case of Diabeties Mellitus , Hypertension , Thyroid dysfunction.

Outcomes

Primary Outcomes

this study is done for symptomatic management of pain in primary dysmenorrhea with ayurvedic tablet kanyalohadi vati

Time Frame: 30 Days

Secondary Outcomes

  • this medicine will help to get rid of painful menses experience , & will not lead to effect the day to day activity(90 days)
  • Symptomatic Relief In The Symptoms(90 Days)

Investigators

Sponsor
Dr Sonal Singh
Sponsor Class
Other [self]

Study Sites (1)

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