| CTRI Number |
CTRI/2019/05/019017 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
08/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of local application of Palash Kshar ointment in Piles. |
|
Scientific Title of Study
|
To study the efficacy of local application of Palash Kshar ointment in the management of Abhyantar Gudarsh with special reference to internal haemorrhoids. : Randomized controlled clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravikumar S Suryawanshi |
| Designation |
Assistant Professor |
| Affiliation |
Vidarbha Ayurved College, Amravati |
| Address |
1, Vaibhav Colony, MIDC Road, Amravati.
MIDC Road
Amravati
MAHARASHTRA
444606
India |
| Phone |
8087842601 |
| Fax |
|
| Email |
ravisuryawanshi4601.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Khandare |
| Designation |
Professor & HOD Shalyatantra Department |
| Affiliation |
|
| Address |
Shalyatantra Department Mahatma Gandhi Ayurved College Hospital and research centre Salod(H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765033585 |
| Fax |
|
| Email |
kbkhandare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravikumar S Suryawanshi |
| Designation |
Assistant Professor |
| Affiliation |
Vidarbha Ayurved College, Amravati |
| Address |
1, Vaibhav Colony, MIDC Road, Amravati.
MIDC Road
Amravati
MAHARASHTRA
444606
India |
| Phone |
8087842601 |
| Fax |
|
| Email |
ravisuryawanshi4601.ms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital & Research Center, Salod (Hirapur), Wardha. |
|
|
Primary Sponsor
|
| Name |
Dr Ravikumar S Suryawanshi |
| Address |
1, Vaibhav Colony, MIDC Road, Amravati |
| 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 Ravikumar Suryawanshi |
Mahatma Gandhi Ayurved College Hospital and Research centre, Salod (H), Wardha |
Salod (Hirapur) Wardha.
Amravati
MAHARASHTRA |
8087842601
ravisuryawanshi4601.ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, DMIMS, DU, Sawangi(Meghe), Wardha |
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, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Control.
Palashkshar Pratisaran. |
Palashkshar Pratisaran locally Once in Adequate quantity. |
| Comparator Agent |
Palashkshar ointment |
Local application of Palashkshar ointment on 0th, 7th, 14th, 21th and 28th day. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical symptoms of internal haemorrhoids will be included in study irrespective of sex, religion, diet habit.
Patients of second and third degree internal haemorrhoids will be included. |
|
| ExclusionCriteria |
| Details |
Patients of piles having previous history of haemorrhoidectomy.
Pregnant woman will not include in this study.
Patients taking other treatment from any pathy for the same problem during clinical trial.
Patients who are suspected of serious systemic disease i.e. DM, TB, malignancy, Syphilis or having portal obstruction
Patients Suspected of carcinoma of rectum, proctalgiafugax, chron’s disease, fistula in ano & where it is contraindicated
Patients with severe anaemia i.e haemoglobin less than 5%. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce per rectal bleeding and degree of internal haemorrhoids. |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To decrease Pain at anal region. (By Visual Analog scale) |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/05/2019 |
| 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
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is open labeled, randomized, controlled study. Palash kshar ointment will be prepared. Clinical study will be carried in two groups. Observation from both group will be noted.will be analysed statistically and will be discussed with conclusion after study. |