Randomised controlled clinical trial to compare the efficacy of Bilwa Magaja Choorna with Nagakeshar Choorna in the management of Raktarsha
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The use of Bilwa Magaja Choorna with Nagkeshar Choorna was effective in reducing Rakta Strava in Raktaarsha.
Study Overview
Brief Summary
Objective
To evaluate and compare the clinical efficacy of Bilwa Magaja Choorna and Nagkeshar Choorna in treating Raktarsha (bleeding haemorrhoids), and to assess potential adverse effects
Background
Raktarsha, a form of Arsha (haemorrhoids), is a common anorectal disorder in Ayurveda, linked to poor diet, sedentary lifestyle, and Agnimandya (impaired digestion).
Modern surgical treatments often have complications; hence, the study seeks safer, cost-effective, Ayurvedic alternatives.
Hypothesis
Null Hypothesis Bilwa Magaja Choorna is as effective as Nagkeshar Choorna.
Alternative Hypothesis Bilwa Magaja Choorna is more effective.
Methodology
Design: Open-label, randomized controlled clinical trial.
Participants: 70 patients (35 in each group) with 1st and 2nd degree Raktarsha.
Intervention
Group A (Trial): Bilwa Magaja Choorna (12 gm) with warm water.
Group B (Control): Nagkeshar Choorna (12 gm) with Navneet and Khadisakhar.
Duration: 14 days with follow-ups on Day 7 and Day 14.
Common Supportive Drug: Gandharva Haritaki Choorna (laxative).
Assessment Parameters
Subjective: Quantity of bleeding per anus.
Objective: Frequency of bleeding.
Investigations: Hb%, HIV, HBsAg.
Inclusion Criteria:
Age 18–60 years, 1st/2nd degree Raktarsha, Hb less than 8 gm%.
Exclusion Criteria
3rd/4th degree haemorrhoids, Hb <8 gm%, pregnancy, HIV/HBsAg positive.
Analysis Tools:
Statistical Tests: Wilcoxon signed-rank test (subjective), t-test (objective).
Knowledge Gap & Rationale:
No prior comparative study on Bilwa Magaja Choorna alone.
Expected to be cost-effective, safe, and easy to administer.
Conclusion:
The study aims to establish Bilwa Magaja Choorna as a potentially more effective Ayurvedic treatment for Raktarsha compared to the standard Nagkeshar Choorna.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients having Raktarsha (1st degree,2nd degree) will be selected.
- •2.Patient with Hb less than 8gm% 3.Patient of age between 18-60 years will be taken.
- •4.Selected of patient will be done irrespective of sex, socioeconomic class, religion.
Exclusion Criteria
- •1.Known case of 3rd and 4th degree haemorrhoids 3rd Degree haemorrhoids- Piles prolapsed during defecation, can be replaced back only by manual help.
- •4th Degree haemorrhoids- piles that are permanently prolapsed
- •Patients with Hb more than 8 gm%
- •Pregnancy
- •Known case of HIV, HBsAg excluded.
Outcomes
Primary Outcomes
The use of Bilwa Magaja Choorna with Nagkeshar Choorna was effective in reducing Rakta Strava in Raktaarsha.
Time Frame: 1st follow up on 7th day and then on 14th day
Secondary Outcomes
- Adverse drug reaction observed during treatment of Raktarsha with Bilwa magaja choorna(1st follow up on 7th day and then on 14th day)
Investigators
Dr Shrikant Balaji Bhosale
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital