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CTRI Number  CTRI/2025/04/085698 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Arsha with Apamarga Kshara Pratisaran and Cryotherapy 
Scientific Title of Study   Efficacy of Apamarga Kshara Pratisaran and Cryotherapy in the management of Arsha (Second degree Haemorrhoids) – An open labelled randomized controlled clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruvi Savaliya 
Designation  P.G. Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9712324031  
Fax    
Email  dhruvisavaliya9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr TSDudhamal 
Designation  H.O.D. 
Affiliation  Institute of teaching and research in Ayurveda Jamnagar 
Address  Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr TSDudhamal 
Designation  H.O.D. 
Affiliation  Institute of teaching and research in Ayurveda Jamnagar 
Address  Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Institute of Teaching and Research in Ayurveda Jamnagar 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dhruvi Savaliya  Institute of Teaching and Research in Ayurveda Jamnagar  Indoor patient department of Shalya Tantra Institute of teaching and research in Ayurveda
Jamnagar
GUJARAT 
9712324031

dhruvisavaliya9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Teaching and Research in Ayurveda Jamnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Apamarga Kshara Pratisaran (Procedure Reference: Sushrut Samhita Sutra Sthana 11, Procedure details: sufficient quantity of Apamarga kshara will be applied on each hemorrhoidal mass for 100 matra (approximately 2 minutes).Duration: Single sitting)
2Comparator Arm (Non Ayurveda)-CryotherapyCryosurgical probe will be applied on the haemorrhoidal mass and the mucosal aspect of anal verge. Ice ball formation 2–3 times i.e. Cryo exposure for approximately 10–15 seconds will be done. Duration: Single sitting
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  (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)
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To find out better treatment of Arsha (Second degree Haemorrhoids).  7th day, 14th day, 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
Redused Recovery time. Easy Pain management. Restoration of physiological function of anus and rectum. Time period to return to routine life style
 
21st day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 hemorrhoidsConservative 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 Cryotherapy in 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.

 
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