| CTRI Number |
CTRI/2025/02/081021 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study for Hemostatic action of Lajjalu lepa and Darvi lepa in Raktarsha -Bleeding piles |
|
Scientific Title of Study
|
A Comparative Clinical Study on Hemostatic action of Lajjalu lepa and Darvi lepa in the Management of RaktArsha-Bleeding piles |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj kumar Yadav |
| Designation |
Associate professor |
| Affiliation |
Sardar Patel institute of ayurvedic medical science and research center Lucknow Uttar Pradesh |
| Address |
Department of Shalya tantra Surgery OPD Number 02 Sardar Patel institute of ayurvedic medical science and research center Kankaha Mohanlal Ganj Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9919895382 |
| Fax |
00 |
| Email |
pankjyad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrutyumjaya Rao Meda |
| Designation |
Director |
| Affiliation |
Sardar Patel institute of ayurvedic medical science and research center |
| Address |
Sardar Patel institute of ayurvedic medical science and research center Kankaha Mohanlal Ganj Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9919895382 |
| Fax |
00 |
| Email |
vinu2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj kumar Yadav |
| Designation |
Associate professor |
| Affiliation |
Sardar Patel institute of ayurvedic medical science and research center |
| Address |
Department of Shalya Tantra Surgery OPD number 02 Sardar Patel institute of ayurvedic medical science and research center Kankaha Mohanlal Ganj Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9919895382 |
| Fax |
00 |
| Email |
pankjyad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya tantra Surgery Room no 02 Sardar Patel institute of ayurvedic medical science and research center Kankaha Mohanlal Ganj Lucknow Uttar Pradesh India Pincode 226012 |
|
|
Primary Sponsor
|
| Name |
Sardar Patel institute of ayurvedic medical science and research center |
| Address |
Sardar Patel institute of ayurvedic medical science and research center Kankaha Mohanlal Ganj Lucknow Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
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 Pankaj kumar yadav |
SPI of Ayurvedic medical science Ganj |
Department of Shalya tantra Surgery Room no 02 Sardar Patel institute of ayurvedic medical science and research center Kankaha Mohanlal Ganj Lucknow UttarPradesh India pin code 226012
Lucknow
UTTAR PRADESH |
9919895382
00
pankjyad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCE LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
bleeding piles |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lajjalu churna , Reference: Charak chikitsasthan chapter no 14 sloka no 21-22, Route: Rectal, Dosage Form: Churna/ Powder, Dose: 05(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Darvi churna , Reference: Charak chikitsasthan chapter no 14 sloka no 21-22, Route: Rectal, Dosage Form: Churna/ Powder, Dose: 05(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvi Lepa, Reference: Charak chikitsasthan chapter no 14 sloka no 21, Route: Rectal, Dosage Form: Churna/ Powder, Dose: 05(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Patient with age group between 20-60 years of age.
2- patient respective of Gender, occupation, socio-economic and marital status.
3-Primary and 1-2 pile mass will be selected.
4- Patient with clinical features of haemorrhoids like, bleeding per rectum, mucous discharge and and 1st,2nd,3rd, degree Haemorrhoids. |
|
| ExclusionCriteria |
| Details |
1-Patient below 20 and above 60 years of age.
2-Secondary piles.
3- Prolapsed,Thrombosed,and strangulated Haemorrhoids.
4- The associate condition like Fistula in ano, fissure in ano, Ulcerative colitis,chorn disease.CA of rectum.
5-Amaemic patient below 8gm%.
|
|
|
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 |
| redused bleeding from piles |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| redused bleeding from pile mass Pain & discomfartness |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/03/2026 |
| 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)
|
Open to Recruitment |
| 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
|
Arsha is a disease afflicting mankind for thousands of years. It could be traced to even Vedic period. Description of similar conditions is also available in other medical literature of the world. In Ayurvedic Literature, this disease is mentioned as one of the ‘Ashtamahagadas’1 and difficult to cure. Nearly 45% of patients attending ano-rectal clinics suffer from the symptoms of Arsha. Ayurvedic physicians regarded this disease as a local manifestation of systemic derangement of doshas. Vitiation of doshas adversely affects the digestive fire resulting in mandagni which in trun lead to constipation. Prolonged contacts of accumulated mala or excretory material taintGudavali resulting in Arshas.2 In spite of progress in modern medicine, there is very little scope in terms of treatment of Hemorrhoids, Surgical techniques of performing hemorrhoidectomy are many and their complications such as pain, anal incontinence, stricture etc are well known. The Major drawback of modern management is lack of clear and unanimous indications of therapy and its limitations. All these modern surgical & Para surgical techniques are associated with post-operative complications which may be early complications such as hemorrhage, secondary infection etc., & late complications such as anal stricture. Anal incontinence, profuse watery discharge etc.,4 |