| CTRI Number |
CTRI/2025/06/088944 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study on the Effectiveness of Suranawleha and Suranvatak in Managing Piles (Haemorrhoids)
|
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Suranawleha and Suranvatak in the management of Shushka Arsha with special reference to Haemorrhoids. |
| 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 Ashlesha Chandrashekhar Vengurlekar |
| Designation |
MS Scholar Shalyatantra Samanya department |
| Affiliation |
Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital, Nashik |
| Address |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital,Kamal nagar, Hirawadi, Panchavati, Nashik
Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8928666184 |
| Fax |
|
| Email |
ashuven99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Raut |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital Nashik |
| Address |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital,Kamal nagar, Hirawadi, Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822979769 |
| Fax |
|
| Email |
dr.aparnaraut12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashlesha Chandrashekhar Vengurlekar |
| Designation |
MS Scholar Shalyatantra Samanya department |
| Affiliation |
Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital Nashik |
| Address |
Department of Shalyatantra Samanya,OPD no 3 ,Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital,Kamal nagar, Hirawadi, Panchavati, Nashik
Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8928666184 |
| Fax |
|
| Email |
ashuven99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra department, OPD no 3, Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital Kamal nagar, Hirawadi, Panchavati, Nashik, Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra,Shree Saptashrungi Ayurveda Mahavidyalay |
| Address |
Shalyatantra department, Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital Kamal nagar, Hirawadi, Panchavati, Nashik, Maharashtra 422003 |
| 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 Ashlesha Chandrashekhar Vengurlekar |
Shree Saptashrungi Ayurveda Mahavidyalay and Hospital ,Kamal Nagar, Hirawadi, Panchavati, Nashik. |
Department of Shalyatantra,OPD no 3
Nashik
MAHARASHTRA |
8928666184
ashuven99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya ,Panchavati,Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Suranawleha , Reference: Sharangdhar sanhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Warm water ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Suranvatak , Reference: Sharangdhar sanhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Warm water ), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having symptoms of Arsha (1st and 2nd degree piles)
2) Patients of age groups 18-60 years irrespective of gender,socioeconomic status .
3) Patients who are willing to participate in the study and ready to give informed written consent |
|
| ExclusionCriteria |
| Details |
1)Thrombosed prolapsed piles, third, and 4th degree piles .
2) Patient suffering from anorectal pathology other than Arsha.
3) Patient below age group under 18 years and above 70 years.
4) Patients suffering from any serious systemic diseases like hypertension, diabetes mellitus , malignancy, Hepatitis B, HIV, HCV, Tuberculosis
5) Bleeding per rectum. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce signs and symptoms of constipation,anal itching in management of Shushka arsha with special reference to Haemorrhoids |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide long term relief & reduce recurrence |
21 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
26/06/2025 |
| 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="6"
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
|
Study Title: A Comparative Clinical Study to Evaluate the Efficacy of Suranawleha and Suranvatak in the Management of Shushka Arsha with Special Reference to Haemorrhoids
Background: Shushka Arsha, correlating with dry-type haemorrhoids, is a common anorectal disease which is well known for its chronicity, recurrences & frequent acute exacerbations .Ayurvedic literature offers various herbal formulations for its management, among which Suranawleha and Suranvatak can be used.
Objective: 1.Primary Objective To study the effect of Suranawleha as compared to Suranvatak in management of Shushka Arsha wsr to Haemorrhoids . 2.Secondary Objective 1) To study in detail Arsha as per Ayurvedic literature. 2) To study in detail Haemorrhoids as per Modern science. 3) To study in detail about the drug Suranawleha.
Design: Comparative clinical trial
Participants: Patients diagnosed with Shushka Arsha (1st & 2 nd degree piles) of ahe group 16-80 years meeting the inclusion and exclusion criteria will be selected from OPD and IPD of Shalyatantra department of Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital, Nashik.
Intervention Groups: Group A: Treated with Suranawleha Group B: Treated with Suranvatak
Duration: Treatment duration:21 days Follow up on 7 ,14 & 21 st day
Assessment Criteria: Symptomatic relief (pain, constipation), reduction in pile mass, and overall quality of life.
Expected Outcome: The study aims to determine which formulation provides better symptomatic relief and therapeutic outcomes, thereby guiding effective Ayurvedic management protocols for haemorrhoids.
Overall Assessment of Therapy: Observations and results will be formulated in accordance with the assessment criteria.
12.Conclusion: The conclusion will be derived exclusively from the statistical analysis.
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