| CTRI Number |
CTRI/2013/08/003875 [Registered on: 05/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ksharasutra (herbal medicated thread) in Fissure (ano-rectal disease) |
|
Scientific Title of Study
|
Role of Ksharasutra in the Management of Parikartika i e Chronic Fissure-in-Ano |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T S Dudhamal |
| Designation |
Assistant professor Department of Shalya Tantra |
| Affiliation |
Institute of post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Shalya Tantra Institute of post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Department of Shalya Tantra Institute of post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof MS Baghel |
| Designation |
Director,IPGT&RA, and Professor Department of Kayachikitsa |
| Affiliation |
Institute of post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for post Graduate Teaching and Research in Ayurveda. Gujarat Ayurved University, Jamnagar. Gujarat
Department of Kayachikitsa Institute of post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427207964 |
| Fax |
02882676856 |
| Email |
baghelayu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T S Dudhamal |
| Designation |
Assistant professor Department of Shalya Tantra |
| Affiliation |
Institute of post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Shalya Tantra Institute of post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Department of Shalya Tantra Institute of post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of post Graduate Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
Institute of post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Shalya Tantra Institute of 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 T S Dudhamal |
opd no 1 Department of Shalya Tantra |
Department of Shalya Tantra Institute of post Graduate Teaching and Research in Ayurveda GAu Jamnagar
Jamnagar
GUJARAT |
9428671939
drtsdudhamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
| IPGTRA institutes ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, patient suffering from chronic fissure in ano, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ksharasutra Suturing at fissure bed and transfixation of sentinel tag |
Sitz bath with sphatikadi qwath two times a day.
Panchasakara churna 5gm at bed time.
Vatagajankusha Vati 250 mg two times a day. |
| Intervention |
Lords anal dilatation followed by Ksharasutra suture. |
Sitz bath with sphatikadi qwath two times a day.
Panchasakara churna 5gm at bed time.
Vatagajankusha Vati 250 mg two times a day. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Parikartika i e Chronic fissure in ano having sign and symptoms like fissure bed with or without sentinel tag
pain in ano
per rectal bleeding
and history of constipation
Chronic fissure in ano associated with Arsha piles and Bhagandara i e fistula in ano
|
|
| ExclusionCriteria |
| Details |
Acute fissure in ano
Carcinoma of ano rectum
Congenital anal stricture and
Congenital anal stenosis patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Ksharasutra in Fissure, cost effective, ambulatory and successful treatment for Parikartika i e chronic fissure in ano |
Weekly after 7 day, 14 days, 21 days and 28 days assessment of relief in sigh and symptoms. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ksharasutra Suturing is cost effective ambulatory and successful treatment for Parikartika i e chronic fissure in ano |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2008 |
| Date of Study Completion (India) |
24/11/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Role of Ksharasutra suturing along with adjuvant therapy in the management of Parikartika
accepted for publication in international Journal of Ayurvedic Medicine a peer reviewed journal ISSN 0976 5921 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Standard Apamarga Ksharasutras were used for treatment of chronic fissure -in ano in both groups Adjuvant Drugs like Sphatikadi yoga 20gm for sitz bath and Jatyadi tail 10ml per rectal instillition were used externally in both groups Panchasakar churna 5g at night and Vatagajankush vati 250mg three times were given for internal use in both groups. In group B (n=50) of kshara sutra suturing with Lords anal dilatation patients cured earlier as compared to patients of group A (n=50) with kshara sutra suturing without Lords anal dilatation. So study concluded that Lords anal dilation had definite role for relaxation of anal sphincters in Parikartika i e chronic fissure in ano During treatment period of 4 weeks as well as follow up period of one month no adverse effect of any drugs or untoward effects of Ksharasutra were noticed as well as reported by any patients. Finallystudy concluded that Ksharasutra Suturing is cost effective, ambulatory and successful treatment in the management of Parikartika i e chronic fissure in ano |