| CTRI Number |
CTRI/2016/12/007562 [Registered on: 09/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
08/12/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of piles with Ayurveda |
|
Scientific Title of Study
|
A Comparative Clinical Study of Apamarga Kshara Application, Infra Red Coagulation and Arshohara Vati in the Management of Arsha |
| Trial Acronym |
TKA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komang Sudarmi |
| Designation |
MS Ayu shalya |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Room no.103 International Hostel, Gujarat Ayurved University Campus , IPGT & RA ,
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8140317114 |
| Fax |
02882676856 |
| Email |
komang.sudarmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTS dudhamal Sambhaji |
| Designation |
M.S (Ayu), PhD (Ayu) |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
room no 638, 6th floor, IPGT & RA, Gujarat Ayurved University,
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
02882676856 |
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Komang Sudarmi |
| Designation |
MS Ayu shalya |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Room no 103 International Hostel Gujarat Ayurved University Campus Jamnagar
GUJARAT
361008
India |
| Phone |
8140317114 |
| Fax |
02882676856 |
| Email |
komang.sudarmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
Director IPGTand RA |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tukaram Dudhamal |
Institute for Post Graduate Teaching and Research in Ayurveda |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
GUJARAT |
09428671939
02882676856
drtsdudhamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC IPGTRA Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients of piles with per rectal bleeding pain in ano constipation feeling of piles , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apamarga Teekshna Kshara Application |
In Lithotomy position, 2% xylocaine jelly will be applied in anal canal for 5-10 minutes. The slit proctoscope is to be inserted to confirm the position of Piles. The pile will be cleaned with normal saline and the prepared Apamarga Kshara will be applied on one pile at one time. After two minutes the Kshara will be removed after proper purple color of pile achieved and washed with Citrus juice. The Shatadhauta Ghrita will be applied. The procedure will be repeated in all piles. The second sitting will be done after 7 days. |
| Comparator Agent |
arshohara vati |
Two tablets of 500 mg will be given orally, three times a day for 15 days after food with plain water orally will be given. |
| Intervention |
Infra Red Coagulation |
In Lithotomy position, 2% xylocaine jelly will be applied in anal canal. The slit proctoscope to be inserted and confirmed the position of Piles. A small fibre optic probe touches the area at base of haemorrhoids, exposing the tissue to a burst of infrared light for about 1.5 seconds maximum 2-5 points will be coagulated at the base of each piles. The same procedure will be done for all piles in the same sitting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 65 years
Patients who were suffering from 1st and 2nd degree Internal Piles
soft deep seated and elevated piles
Controlled case of hypertension diabetes mellitus and Cardiac disorders
|
|
| ExclusionCriteria |
| Details |
Age less than 16 years and more than 65 years
3rd and 4th degree piles
Rectal prolapsed
Patients of Acute and Chronic anal fissure
Haemorrhoids associated with Fissure and fistula in Ano
Uncontrolled Hypertension Diabetes Mellitus Cardiac disorders
Malignancy
Pregnant women
Hepatitis B Tuberculosis HIV VDRL positive cases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
relief in sign and symptoms of piles
avoiding recurrence |
relief in sign and symptoms of piles
avoiding recurrence |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve quality of life |
medicinal and non surgical management of piles |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
23/12/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
no publication till date |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total 30 patients of first and second grade piles will be selected from OPD of shalya tantra and randomly divided into three groups. In group A 10 patients will be treated with local application of tikshna Apamarga kshara in four sittings under aseptic precaution. In group B 10 patients will be treated with application of infrared coagulation in four sittings. In group c 10 patients will be treated with Arshohara Vati 500 mg three times a day orally. In all group patients will be treated for four weeks and they will be followed up for further two weeks. The assessment of results will be done on the basis of relief in sign and symptoms by adopting gradation system. The observed findings will be recorded in research proforma and statistical test will be applied for significance. The final conclusion will be drawn with comparative effect of these three interventions.
|