Management of Arsha with Apamarga Kshara Pratisaran and Cryotherapy

Phase 2/3

Not yet recruiting

Conditions: Second degree hemorrhoids. Ayurveda Condition: ARSAH,

Registration Number: CTRI/2025/04/085698

Lead Sponsor: Institute of Teaching and Research in Ayurveda Jamnagar

Brief Summary: Haemorrhoids are symptomatic enlargements of the internal haemorrhoidal venous plexus. Internal haemorrhoids characteristically lie in the 3, 7 and 11 o’clock positions (with the patient in the lithotomy position). The worldwide prevalence of Haemorrhoids is around 4.4%. The incidence of this disease is showing augmentation with advancing age. At least 50% of the people over the age of 50 years have some degree of symptoms related to hemorrhoids*.*Conservative medical treatment of haemorrhoids includes use of fiber supplements; lifestyle modifications may include relieving constipation, avoiding straining, proper fluid intake, better anal hygiene and sitz baths. If the patients do not respond to conservative measures, rubber band ligation (RBL), sclerotherapy, infrared coagulation (IRC) and cryosurgery are some outpatient department (OPD) procedures. Surgery, i.e. haemorrhoidectomy, for haemorrhoids is indicated in fourth grade when symptoms of bleeding, pain and prolapsed piles compromise the quality of life. Cryotherapy is a type of surgery that involves the use of extreme cold to destroy 1st and 2nd degree haemorrhoids. *Arsha* (Haemorrhoids) is considered as one among the eight grave diseases (*Ashta mahagada*) in *Ayurveda*by Acharya Sushruta. Detailed explanation of *Arsha* including etiology, types, clinical features and various treatment options are given in *Sushruta samhita* and *Charak Samhita* also. The treatment options given in *Samhita* are *Bheshaja chikitsa* (medicine), *Ksharakarma* (use of *Kshara/Ksharasutra), Agnikarma* (cauterization) and *Shastrakarma*(surgery). *Kshara* is alkaline in nature derived from a combination of various herbs that is applied to the pile mass with the help of a special slit proctoscope. *Sushruta* had mentioned various drugs including *Apamarga* for preparing *Kshara.*He has also mentioned *kshara pratisaran* method in the management of *Arsha*. The present study has been planned to evaluate and compare the clinical efficacy of*Apamarga Kshara Pratisarana*and Cryotherapyin the management of *Arsha* (Second degree Haemorrhoids). In this trial, Diagnosed cases of *Arsha* (Second degree Haemorrhoids) will be selected from OPD and IPD of hospital of I.T.R.A., Jamnagar irrespective of caste, religion, gender and socioeconomic status and will be allocated randomly into two group (minimum 20 in each group). Intervention arm: will be treated by *Apamarga Kshara Pratisarana*for 100 *matra kaal*in single sitting and comparator arm will be treated with Cryotherapy in single sitting. Parameters such as pain, bleeding per rectum, protrusion of pile mass and Constipation will be assessed and marked on specifically designed research proforma. Follow up will be done on 7th,14th and 21st post operative days. In this study, obtained data will be analyzed on the basis of proper logics and reasoning to find out the comparative efficacy of *Apamarga Kshara Pratisarana* and Cryotherapy in the management of *Arsha* (Second degree Haemorrhoids) and further conclusions will be derived from the study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

(1)Age of patients – 18 to 60 years irrespective of gender, religion, education and socioeconomic status (2)Patients with primary and uncomplicated Arsha (Second degree Hemorrhoids) (3)Patients of Arsha (Second degree Hemorrhoids) without fissure or fistula in ano (4)Patients of Arsha (Second degree Hemorrhoids) with controlled Hypertension (BP less than 160/90mmHg) and Diabetic Mellitus (RBS less than 140mg/dl).

Exclusion Criteria

1)Age less than 18 years and more than 60 years.(2)Patients with 1st,3rd and 4th degree Haemorrhoids.(3)Patients having Shushkarsha.(4)Patients having rectal prolapse, fissure and fistula in ano (5)Known cases of Malignancy, Tuberculosis, Uncontrolled Hypertension, Diabetes Mellitus, Cardiac disorders (6)Pregnant women and lactating mother(7)Who were Unfit for surgery (8)Patients of HIV, HBsAg, VDRL, HCV Positive (9)Secondary Pathological Hemorrhoids e.g. Infective and Neoplastic conditions of Rectum, Rectal prolapse, Crohn’s disease and Ulcerative Colitis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out better treatment of Arsha (Second degree Haemorrhoids).	7th day, 14th day, 21st day

Secondary Outcome Measures

Name	Time	Method
Redused Recovery time. Easy Pain management. Restoration of physiological function of anus and rectum. Time period to return to routine life style

Trial Locations

Locations (1): Institute of Teaching and Research in Ayurveda Jamnagar
🇮🇳
Jamnagar, GUJARAT, India
Institute of Teaching and Research in Ayurveda Jamnagar
🇮🇳Jamnagar, GUJARAT, India
Dhruvi Savaliya
Principal investigator
9712324031
dhruvisavaliya9@gmail.com