A randomised controlled clinical trial to study the effect of hingvadi churna in katishula with special reference to sutika roga .
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To assess the effect of hingvadi churna in katishula with special reference to sutika roga with the help of assessment criteria after 14 days of treatment
Study Overview
Brief Summary
Womens health is crucial not only for the individual but also for the society. In
today’s society, postpartum women face various health issues due to lifestyle
changes, stress, and strain Many mothers complain of physical problems like back
pain and joint pain after delivery. Sutika katishula is commonest condition. It can be a cause of many Abnormal dietics or lifestyle or because of improper garbhini paricharya or sutika paricharya. The prevalence rate of sutika katishula is 33.33%.In modern science, treatment of katishula is analgesics which subside the pain temporarily and causes side effect if used for a longer period of time as well as affects
baby through breast feeding. In ayurveda the main aim is vatahara which in turn ( pacifies the vata) and
increasing the agni. Line of treatment is vatahara and agnidipana. Hingavadi churna has same properties. The contents of this drug are easily available and cost effective and has more efficient properties to cure sutika katishula. The clinical study of Hingavadi churna has not been yet accessed in sutika katishula so it will help to fill knowledge gap. Study includes the female patient having sign and symptoms of sutika katishula between age group of 18-35 year who fulfill terms of inclusion criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Total Sample size is 70 and is calculated by using Daniel 1999 formula. 35 patients in each group. Simple random sampling technique will be used. Total number of patients is 70 which is divided into two groups named as Group A ( trial group) and group B ( control group). Hingvadi churna is given to group A ( Trial group ) and chaturbeej churna is given to group B ( control group). Drugs will be purchased from GMP certified pharmacy. Both drugs will be administered for 14 days. All SOP of churna preparation will be followed throughout the clinical trial. Observation will be done on 0th day, 7th day and 14th day. Scale used for assessment will be Oswestry Disability Index scale. Results will be drawn on the basis of assessment criteria and Statistical analysis.Discussion will be carried out on the basis of observation and result obtained during treatment. Summary will be drawn and the thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •The signs and the Symptoms of puerperal women after normal delivery Full-term normal delivery irrespective of parity and gravida Married women.
- •Patients between 18 -35 years of age.
- •Patient willing to give written consent.
Exclusion Criteria
- •L.S.C.S. Previous operations Patients with known case of Spine disorders Patients with Any previous surgeries/ lumbar / abdominal surgery Patients unwilling to give informed written consent.
- •Age group below 18 years and above 35 years.
- •High-risk pregnancies associated with known case of PIH, Pre- Eclampsia, Eclampsia, PPH, CPD.
Outcomes
Primary Outcomes
To assess the effect of hingvadi churna in katishula with special reference to sutika roga with the help of assessment criteria after 14 days of treatment
Time Frame: Reduction in signs and symptoms of katishula in sutika after 14 days of treatment
Secondary Outcomes
- To study effectiveness of trial and control group(18 months)
Investigators
Dr Vama Hitesh Sanghvi
SMBT Ayurved college and hospital