| CTRI Number |
CTRI/2021/03/031801 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
27/06/2021 |
| 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
|
Effect of Jalaukavacharana and Triphala Guggulu with Moolakadi Avgaahan in Thrombosed Haemorrhoids |
|
Scientific Title of Study
|
A Comparative Study between the effect of Jalaukavacharana and Triphala Guggulu with Moolakadi Avgaahan in the management of Arsha wsr to Thrombosed Haemorrhoids |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kulwant Singh Himaliyan |
| Designation |
Senior Lecturer |
| Affiliation |
R. G. G. P. G. Ayurvedic College and Hospital Paprola |
| Address |
P.G. Deptt. Of Shalya Tantra
R. G. G. P. G. Ayurvedic College and Hospital
Paprola, Kangra. 176115 (H.P.)
P.G. Deptt. Of Shalya Tantra
R. G. G. P. G. Ayurvedic College and Hospital
Paprola, Kangra. 176115 (H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418251550 |
| Fax |
|
| Email |
drkulwanthimaliyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kulwant Singh Himaliyan |
| Designation |
Senior Lecturer |
| Affiliation |
R. G. G. P. G. Ayurvedic College and Hospital Paprola |
| Address |
P.G. Deptt. Of Shalya Tantra
R. G. G. P. G. Ayurvedic College and Hospital
Paprola, Kangra. 176115 (H.P.)
P.G. Deptt. Of Shalya Tantra
R. G. G. P. G. Ayurvedic College and Hospital
Paprola, Kangra. 176115 (H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418251550 |
| Fax |
|
| Email |
drkulwanthimaliyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankush Kushal |
| Designation |
PG Scholar |
| Affiliation |
Deptt. of Shalya Tantra,Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
08894956629 |
| Fax |
|
| Email |
ankushkushal7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy |
| Research Institue in I.S.M. Jogindernagar |
| RGGPG Ayu College and Hospital |
|
|
Primary Sponsor
|
| Name |
Principal cum Dean RGGPG Ayurvedic College and Hospital Paprola |
| Address |
R.G.G.P.G. Ayurvedic College and Hospital
Paprola, Kangra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
P.G. Deptt. Of Shalya Tantra
R. G. G. P. G. Ayurvedic College and Hospital
Paprola, Kangra. 176115 (H.P.) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankush Kushal |
P.G. Deptt. of Shalya Tantra, RGGPG Ayu College and Hospital Paprola |
O.P.D. 105, P.G. Department of Shalya Tantra, RGGPG Ayu College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
889495629
ankushkushal7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) RGG PG Ayu College and Hospital Paprola Kangra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K645||Perianal venous thrombosis. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jalaukavacharana |
Blood letting from the thrombosed and prolapsed mass of hemorrhoids using a medicinal Leech. A duration of total 21 days i.e. Three sittings at an interval of 7 days and a follow up after a month. |
| Comparator Agent |
Oral Medication (Triphala Guggulu) and Avgaahana (Moolakadi Avgaahaan) |
Tablet Triphala Guggulu 1g Thrice a day with luke warm water per os and Sits Bath with Moolakadi Avgaahaan twice a day to the control group for 21 days along with a follow up after a month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients willing for trial.
b.Patients age group 20-70 years of either sex.
|
|
| ExclusionCriteria |
| Details |
a.Patients not willing for trial or not ready to give informed consent.
b.Patient below age of 20 years and above 70 years of age.
c.Patients with uncontrolled systemic disorders, Immunocompromised, Endocrinal disorders or any Hemorrhagic disorders.
d.Lactating or Pregnant Female
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief of signs and symptoms of the of the disease |
21 days (3 sittings after every 7 days) and Follow up after a month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minimal to No discomfort with the Disease after treatment |
One Month at follow-up |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2021 |
| Date of Study Completion (India) |
31/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research trial work after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of R.G.G.P.G.Ayu. College and hospital Paprola, Kangra (H.P.). A control Group of 10 patients along with a trial group of 10 patients will be registered and assessed based on subjective and objective criteria. Effect of Jalaukavacharana will be documented along with it’s comparison with Triphala Guggulu and Moolakaadi Avgaahana. |