| CTRI Number |
CTRI/2025/03/083142 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of Suranadi lepa and Nagaradi modaka in Piles |
|
Scientific Title of Study
|
Pharmaceutico Analytical study of Suranadi lepa & Nagaradi modaka and its comparative clinical study in the management of Arshas |
| 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 BUMTARIYA SAGARKUMAR TULSHIBHAI |
| Designation |
Post Graduate Scholar |
| Affiliation |
Dr.NRS Govt Ayurvedic College, Vijayawada |
| Address |
Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh.
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
7046817468 |
| Fax |
|
| Email |
bumtariyasagarkumar1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K SREEHARI |
| Designation |
PROFESSOR |
| Affiliation |
Dr.NRS Govt Ayurvedic College, Vijayawada |
| Address |
Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh.
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9491925109 |
| Fax |
|
| Email |
dr.skovi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BUMTARIYA SAGARKUMAR TULSHIBHAI |
| Designation |
Post Graduate Scholar |
| Affiliation |
Dr.NRS Govt Ayurvedic College, Vijayawada |
| Address |
Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College M.G Road, Vijayawada, Andhra Pradesh.
ANDHRA PRADESH
520002
India |
| Phone |
7046817468 |
| Fax |
|
| Email |
bumtariyasagarkumar1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Achanta Lakshmipathi Government Ayurvedic Hospital
D. no. 23, 37-112, Near vijaykrishna super bazar, MG Road,
Vijaywada, Andhra Pradesh, India Pin code : 520002 |
|
|
Primary Sponsor
|
| Name |
Dr BUMTARIYA SAGARKUMAR TULSHIBHAI |
| Address |
Department of Rasa shastra and Bhaishajya Kalpana Dr N R S Government Ayurvedic College D. No. 23, 37-112, Near Vijayakrishna Super Bazar M.G Road, Vijayawada, Andhra Pradesh India, Pin Code: 520002 |
| Type of Sponsor |
Other [P G Scholar in Government Ayurvedic 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 BUMTARIYA SAGARKUMAR TULSHIBHAI |
Dr Achanta Lakshmipathi Government Ayurvedic Hospital |
Department of Shalya tantra First floor OPD Number : 8
Krishna
ANDHRA PRADESH |
7046817468
bumtariyasagarkumar1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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, (2) 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 | Drug | Classical | | (1) Medicine Name: Nagaradi modaka, Reference: Bhaisajya Ratnavali 9th chapter 60-61 shloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: -(2) Medicine Name: Suranadi Lepa, Reference: Bhaisajya Ratnavali 9th chapter 11 shloka, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Suranadi Lepa , Reference: Bhaisajya Ratnavali 9th Chapter 11 shloka, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age of patient between 22 to 60 years irrespective of sex, religion and Occupation.
2.Arshas having complete history of 1st & 2nd Degree.
3.Patient presenting with Nidana, Lakshana, & Samprapati of Arsha.
4.Who are willing to participate.
5.Patient Complaining of Gudgat Raktasrava, Gudgat Kandu, Gudpida, Shotha, Agnimandhya,Malavastambha.
|
|
| ExclusionCriteria |
| Details |
1.Ca Rectum
2.Perianal abscess
3.Piles with fissure
4.Piles with fistula
5.Prolapsed Rectum
6.Crohn’s disease
7.Ulcerative colitis
8.Proctitis
9.Rectal Polyp
10.Condyloma
11.Anal epithelioma
12.HIV & Hepatitis
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms and signs like itching pain swelling bleeding constipation |
20 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Appetite increases, relief of constipation |
20 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bumtariyasagarkumar1999@gmail.com].
- For how long will this data be available start date provided 15-03-2025 and end date provided 15-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Worldwide, The Prevalence of Symptomatic Hemorrhoids is estimated at 4.4% in the general population. Ø According to WHO 40% of people world wide are suffering from Hemorrhoids. Ø Hemorrhoids affect 75% of adult in their lifetime. Ø This condition is very common, Affecting around 1 in 20 People in India. Ø About, Half of the population have hemorrhoids by age 50. Ø In India approximately 80% sufferers are in age group of 21 to 50. Ø In Ayurveda, we correlate the disorder of Hemorrhoids with Arshas Ø Modern conservative therapy include non-surgical modality like injection Ø sclera therapy , cryotherapy manual dilatation of anus, electrocoagulation ,rubber band ligation, stapler etc., but this modality require many specialized equipment. Ø Fortunately only 10% of patients have severe symptoms enough to require these interventions. Ø So with all these concerns Ayurvedic conservative therapy is required which include diet, lifestyle and medicine. Ø Hence, in this research, an attempt is made to evaluate the effect of “Suranadi Lepa & Nagaradi Modaka” in the management of Arshas. |