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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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)
| 2 | Comparator Arm (Non Ayurveda) | | - | Cryotherapy | Cryosurgical 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)
|
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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
|
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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 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 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. |