CTRI Number |
CTRI/2017/10/009963 [Registered on: 03/10/2017] Trial Registered Retrospectively |
Last Modified On: |
25/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To Know the most effective treatment in between medicated thread of Apamarg and lateral cut inside to the sphincter in Chronic Fissure in Ano |
Scientific Title of Study
|
A comparative clinical study of Apamarg Ksharasootra and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-In-Ano)-A open randomized Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Gajiram Dharamdas Banothe |
Designation |
PhD Scholar |
Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Address |
Department of Shalyatantra IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
7046243508 |
Fax |
|
Email |
amanbanothe@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr T S Dudhamal |
Designation |
Associate Professor |
Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Address |
Department of Shalyatantra I P G T and R A GAU Jamnagar Department of Shalyatantra I P G T and R A GAU Jamnagar Jamnagar GUJARAT 361008 India |
Phone |
9428671939 |
Fax |
|
Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Gajiram Dharamdas Banothe |
Designation |
PhD Scholar |
Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Address |
Department of Shalyatantra IPGT and RA GAU Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
7046243508 |
Fax |
|
Email |
amanbanothe@gmail.com |
|
Source of Monetary or Material Support
|
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat |
|
Primary Sponsor
|
Name |
Not Any |
Address |
Not Any |
Type of Sponsor |
Other [] |
|
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 |
Gajiram Banothe |
Institute for Post Graduate Teaching and Research in Ayurveda |
Room no 630 6th floor Department of Shalya Tantra IPGT and RA Jamnagar GUJARAT |
7046243508
amanbanothe@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Fissure in Ano, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Apamarga Ksharasootra |
medicated thread prepared by 13 coating of snuhi kshira followed by 5 coatings of snuhi plus apamarga ksharafollowed by 3 coatings of haridra |
Comparator Agent |
lateral internal sphincterotomy |
a surgical method used to incise internal sphincter |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of Parikartika (Chronic fissure-in-ano) having duration more than 6 months.
Age group between 18-60 years.
|
|
ExclusionCriteria |
Details |
1) Fissure-in-ano having duration- less than 6 months.
2) Chronic fissure-in-ano associated with piles & fistula.
3) Patient below 18 & above 60 years of age
4) Patient suffering from HIV, VDRL, HepatitisB, T.B.
5) Uncontrolled cases of Diabetes Mellitus and Hypertension.
6) Patient suffering from malignancy.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Apamarga Ksharasootra is more effective than lateral internal sphincterotomy |
1 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
lateral internal sphincterotomy is more effective than apamarga ksharasootra |
0, 7th , 14th, 21th, 30th day |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
19/08/2017 |
Date of Study Completion (India) |
04/01/2019 |
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
Modification(s)
|
Banothe Gajiram D.& Dudhamal T.S.: Ksharasutra Transfixation And Ligation In The Surgical Management Of Chronic Fissure In-Ano - A Case Report. International Ayurvedic Medical Journal {online} 2019
Gajiram D. Banothe and T. S. Dudhamal. Management of Chronic fissure in ano by Ksharasutra (medicated thread): A Clinical Prospective Study. Int. J. Res. Ayurveda Pharm. 2020;11(4):45-49 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
SUMMARY
The research study entitled “A
comparative clinical study of Apamarg
Ksharasootra and Lateral Internal Sphincterotomy in the management of Parikartika (Chronic Fissure-In-Ano)- An open randomized Trial. †Aim and
Objective of this study was to compare Apamarga
Ksharasootra application and Lateral Internal Sphincterotomy in the
management of Parikartika (Chronic
Fissure-in-ano). This trial is summarized in Literature review, Ayurvedic literature
& Modern literature of Parikartika (Chronic
Fissure in ano). For this trial Null
hypothesis (H0) was the effect of Apamarga
Ksharasootra and open lateral internal sphincterotomy in the management of Parikartika (Chronic fissure in ano) will be same. Alternative hypothesis
(H1) was the effect of Apamarg
Ksharasootra application and Latral Inernal Sphincterotomy in the
management of Parikartika (Chronic fissure in ano) will not be same. Drug
review included description of Apamarga
Kshara and Ksharasootra Preparation,
SOP of Kshara preparation and their
ingredients detail with their properties and mode of action were discussed with
classical references. Adjuvant drugs was given in both groups were also
discussed with their probable mode of action.
Total
105 patients of Parikartika (Chronic
Fissure in Ano) were selected & randomly divided by computerized randomized
table. In Group A (n=52) patients treated with trial Ksharasootra application with maximum possible anal dilatation was
done while in group-B (n=53) Lateral Internal Sphincterotomy (LIS) was done
under LA. or S.A. Jatyadi Taila Matra
Basti, Panchawalkala Kwatha for
Avagaha Swedana, Erandbhrishta Haritaki orally for laxative were used in
post-operative period as adjuvant drugs in both groups. Before treatment,
routine hematological, biochemical, urine examination were carried out. The
assessment was made on the basis of relief in pain, oozing and days required
for complete wound healing after operation. In this study, assessment was done
on 7th day, 14th day, 21st day and on 30th post-operative day and Follow up was
taken after 1 month. The observed results in the study were subjected to
statistical calculation to derive final conclusion.
The
discussion was made on all demographic observations and clinical findings i.e.
In group-A average 11.75 days required for relief in pain in ano while in
group-B average 09.84 days required for relief in pain in ano, which shows the
patients of Group-B got relief in pain earlier than patients of Group-A. In
this study, it was observed that 92.16% patients got relief in post-operative
oozing of blood till 1st week in group-A, 100% patients got relief in P/R
bleeding within 14th days in group-A and 89.26% patients got relief in P/R
bleeding within 7th days in group-B. This means after Sphincterotomy more days
required for stoppage of oozing of blood. It was observed that 50.00% patients
got relief in post-operative swelling till 1st
week in group-A, 100% patients got relief in post-operative swelling
within 14th days in group-A and 33.33%
patients got relief in post-operative swelling within 7th days in group-B and
100% patients got relief in post-operative swelling within 14th days. Vibandha (Constipation) was relieved in
49 patients of Group-A and 48 patients of Group-B have constipated bowel (Vibandha) which was relieved within 7 days. In 83.50% patients
of Group A and 16.49% of patients of Group B needed other laxative drug for
relief in constipation after operation.
Conclusion-
In both groups highly significant results were found statistically but early
relief in post-operative pain were observed in Group-B (Lateral Internal
Sphincterotomy with excision of skin tag) whereas early relief in
post-operative swelling and oozing were observed in Group-A (Ksharasootra application with maximum
possible anal dilatation).
Hence
Null hypothesis (H0) is rejected and Alternative hypothesis (H1) is accepted
i.e. a significant effect of Apamarg
Ksharasootra application in the management of Fissure in ano. |