| CTRI Number |
CTRI/2025/04/085698 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2026 |
| 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)
|
|
| 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)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| Date of Study Completion (India) |
05/08/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study, entitled “A Comparative Clinical Study of Apamarga Teekshna Kshara Pratisaran and Cryotherapy in the Management of Arsha (Second-Degree Internal Haemorrhoids)”, concluded that both treatment modalities were safe, effective, minimally invasive, and suitable for day-care management. Both groups showed highly significant improvement in postoperative pain, bleeding per rectum, protrusion of pile mass, constipation, and overall symptom score, with most patients achieving complete clinical remission by the 21st postoperative day. No statistically significant difference was observed between the groups in any major clinical parameter or overall outcome. No major adverse events or serious postoperative complications were reported. Apamarga Teekshna Kshara Pratisaran offers the additional advantages of being simple, economical, and not requiring specialised equipment, while cryotherapy is an established minimally invasive technique. Thus, both modalities demonstrated comparable clinical efficacy, and the null hypothesis was not rejected. |