| CTRI Number |
CTRI/2025/08/093523 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Arshas (Haemorroids) with Arsha Kuthara Lepa and Haridradi Lepa: A Comparative Study. |
|
Scientific Title of Study
|
A Comparative Clinical Study of Arsha Kuthara Lepa and Haridradi Lepa in the Management of Arshas W.S.R Haemorroids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varshdeep Singh |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ramakrishna Ayurvedic Medical college, Hospital and Research Centre |
| Address |
Department of Shalya Tantra of PG Studies, Ramakrishna Ayurvedic Medical college, Hospital and Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bengaluru
Bangalore Rural
KARNATAKA
560064
India |
| Phone |
9653945077 |
| Fax |
|
| Email |
varsh000s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anumarlapudi Jayaram |
| Designation |
HOD and Professor |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Shalya Tantra of PG Studies, Ramakrishna Ayurvedic Medical College, Hospital and Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bengaluru
Bangalore Rural
KARNATAKA
560064
India |
| Phone |
8147926918 |
| Fax |
|
| Email |
anumarlapudi_j@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anumarlapudi Jayaram |
| Designation |
HOD and Professor |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital and Research Centre |
| Address |
Department of Shalya Tantra of PG Studies, Ramakrishna Ayurvedic Medical College, Hospital and Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bengaluru
Bangalore Rural
KARNATAKA
560064
India |
| Phone |
8147926918 |
| Fax |
|
| Email |
anumarlapudi_j@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Ayurvedic Medical College, Hospital and Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bengaluru-560064 |
|
|
Primary Sponsor
|
| Name |
Dr Varshdeep Singh |
| Address |
Ramakrishna Ayurvedic Medical college, Hospital and Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bengaluru - 560064 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Varshdeep Singh |
Ramakrishna Ayurvedic Medical college, Hospital and Research Centre |
Department of Shalya Tantra of PG Studies, Ramakrishna Ayurvedic Medical college, Hospital and Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bengaluru-560064
Bangalore Rural
KARNATAKA |
09653945077
varsh000s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramakrishna Ayurvedic Medical college, Hospital and Research Centre Ethical Clearance Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arsha Kuthara Lepa, Reference: Acharya Siddhinandan Mishra, Rasaratna Samuchaya, Chaukhambha Orientalia Varanasi.2011, Chapter no-15-Arshachikitsa, verse no.83, pg no-355, Route: Rectal, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridradi Lepa, Reference: Vaidya Laksmipati Sastri, Yogaratnakara, edited by Bhisagratna Brahmasankar Sastri, Chaukhambha Prakashan Varanasi.2007, Chapter- Arshanidana, verse no.5, pg no-308, Route: Rectal, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.The Participants diagnosed with first and second- degree internal Haemorrhoids.
2.The participants with age 20 - 70 years.
3.Irrespective of sex, religion, occupation and economic status.
4.With or without other ano rectal diseases, other than those specified in the exclusive criteria. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Bleeding per rectum, pruritus ani, mucous discharge, size of pile mass and number of pile mass |
Observation will be done on 5th,10th,15th and follow up once in 15 days, once in 30 days for further re-occurrence |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/09/2025 |
| 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="2"
Months="1"
Days="10" |
|
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
|
This is a postgraduate academic clinical study conducted to compare the therapeutic effects of Arsha Kuthara Lepa and Haridradi Lepa in the management of Arshas with special reference to Haemorrhoids. Arshas is a form of mamsankura formed in rectum due to dosha vitiation along with vitiation of twak, mamsa, medas. According to Ayurvedic classics it is one among Ashtamahagadas - describe as like the pain inflicted by brutal enemy. Two classical Ayurvedic Lepa formulations Arsha Kuthara Lepa and Haridradi Lepa are administered through rectum for a specified duration under standard Shayla tantra protocols. The primary objective of the study is to assess and compare the reduction in parameters such as Bleeding per rectum, pruritus ani, mucous discharge, size of pile mass and number of pile mass. Participants will be randomly allocated into two groups. The treatment will be given for 7 days, followed by a follow up on 15th day. The outcome will be help evaluate the comparative efficacy of these two classical formulations in the management of Arshas and explore their role in improving quality of life in patients suffering from Arshas. |