A randomized controlled clinical study to evaluate the efficacy of Jatiphaladi Vati in Arsha with special reference to 1st and 2nd Degree Internal Haemorrhoids.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Relief in pain in ano.
Study Overview
Brief Summary
Haemorrhoid is a one of the anorectal disorder which is commonly seen in the society. According to Modern Science ,Arsha is correlate with Haemorrhoid .Haemorrhoid is a varicosity and Dilatation of haemorrhoidal veins of anal canal .As Per Ayurveda The Disease ’Arsha ’ comes under the heading of Maharogas .Because it dushchikitsy,,dirghakalanubandhi and involves the Marma.Arshas is a clinical condition in which structural derangement take place. As per ayurveda, the vitated doshas (vatta,pitta ,kapha )contaminate the twak,mansa,rakta,meda and hampers the function of apan vayu , causes Mansa ankuras at the anal opening .Heamorrhoids is very common ano rectal disease.About 50% to 60% of the people will have heamorrhoid at same point in their lives.Haemorrhoids have conservative as well as surgical treatment as like Cryosurgery,Dilatation, Haemorrhoidectomy, Heamo rrhoid stapling , Rubber band ligation and Sclerotherapy, but not all of them have been uniformly successful. As compared to conservative treatment surgical procedure are expensive, post opeartive pain is unbearable.so patient are not willing for surgical intervention..In Ayurveda Bhaishajakarma is the first line of treatment because there is no fear of complication,bleeding and putrification in comparison of others.Ayurveda has mentioned many herbal formulation of arshas. Hence a randomized controlled clinical study to evaluate the efficacy of Jatiphaladi Vati in arsha with special reference to 1st and 2nd degree internal haemorrhoids study was undertaken.
In this study 80 patients will be randomly selected showing signs and symptoms of internal haemorrhoids and are randomied into 2 groups.Trail group will be treated with the standared treatment with Jatiphaladi Vati while control group will be treated with ayurvedic prepration Tab.Pilonash. In clinical study patient will be examined according to subjective criteria which includes 1.Gudgatraktastrav (Per rectum bleeding),2.Gud Kandu (Anal itching),3.Gudshool (Pain at anal region)by Visual Analogue Scale and objective Criteria Including 1.Degree Of Pile, 2.Malavshtambha(Constipation), by Victoria Bowel Perfomance Scale 3.Laboratory Blood Chemistry Tests as under 1.CBC,2.BT,3.CT,4.Stool examination for occult blood if required.The observations will be drawn after completion of clinical study and conclusion will be drawn accordingly. The study will be published after completion of trail.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient Diagnosed with 1st and 2nd degree of Internal Haemorrhoids of both sexes.
- •Patients having following Clinical features of Arsha.
- •a)Agnimandya b)Saraktamala Pravrutti c)Gudashool d)Malavshtambh e)Gudakandu 3)Patient willing to participate with informed written consent.
Exclusion Criteria
- •1.Pregnant women and lactating mother 2.Severe anaemic patient 3.Patient having systemic disorders like portal hypertension,liver cirrhosis 4.Patient having immunocompromise disordres 5.Bledding disorders like haemophillia and purpura.
Outcomes
Primary Outcomes
Relief in pain in ano.
Time Frame: 28 days
Stopage of per rectal bleeding
Time Frame: 28 days
Anal itching
Time Frame: 28 days
Secondary Outcomes
- Decrease in symptoms like bleeding per rectum,itching and pain at anal region(28 days)
Investigators
Dr Bhausaheb Prataprao Suryawanshi
Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik