| CTRI Number |
CTRI/2023/08/056483 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study Of Saindhawadi Churna In Management Of Arsha With Special Reference To First And Second Degree Hemorrhoids |
|
Scientific Title of Study
|
Open Randomized Control Clinical Trial Of Efficacy Of Saindhawadi Churna In The Management Of Arsha With Special Reference To First And Second Degree Internal Hemorrhoids |
| 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 Nikhil Uttam Nigade |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
OPD No 13 Shalyatantra OPD Ground Floor Dhanvantari Hospital Ashta Tal Walva Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9405810463 |
| Fax |
|
| Email |
nikhilnigadeaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Sarjerao Dange |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Shalyatantra Of Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walva Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
dr.vijaydange@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Sarjerao Dange |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Shalyatantra Of Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walva Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
dr.vijaydange@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil Uttam Nigade |
| Address |
OPD No 13 Shalyatantra OPD Ground Floor Dhanvantari Hospital Ashta Tal Walva Dist Sangli |
| 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 Nikhil Uttam Nigade |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
OPD no 13 Shalyatantra OPD Ground Floor Dhanvantari Hospital Ashta Tal Walva Dist Sangli
Sangli
MAHARASHTRA |
9405810463
nikhilnigadeaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Institutional Ethics Committee |
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: Saindhawadi Churna, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kankayan Vati, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with the Lakshana of Arsha
2 Patients of both genders between the age group of 20 to 60 years
3 Patients of Internal Hemorrhoids of all position with First and Second degree of Internal Hemorrhoids |
|
| ExclusionCriteria |
| Details |
1 Pregnancy and lactating women
2 Arshas associated with other anorectal colon conditions like Fissure Fistula in ano Polyps Ulcerative Colitis Sinus Malignancy Vascular Anomalies Abscess Bleeding Piles
3 Patients with Systemic Diseases like Hypertension Diabetes
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of Saindhawadi Churna in management of Arsha |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Saindhawadi Churna And Kankayan Vati in management of Arsha |
4 Weeks |
|
|
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)
|
28/08/2023 |
| 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
|
As we see the number of patients of Arsha are increasing day by day due to their sedentary lifestyle so this study will give relief from Arsha symptoms and other complications to patients . This study is randomized open controlled clinical trial to evaluate the efficacy of Saindhawadi Churna in management of arsha as a trial drug and Kankayan Vati as a control drug . Trial and control drugs administrates in the form of Churna and Vati respectively in diagnosed cases of arsha or first and second degree internal hemorrhoids for 7 days ie 2 gm by in a day . 10th day follow up day . 35 patients will be in each groups will be studied . Study will conduct in India . Outcome of study will be assess on reduction of symptoms of Arsha . |