| CTRI Number |
CTRI/2022/08/044854 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
01/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of Agnikarma using Panchaloha shalaka in comparison with Diathermy in
partial internal sphincterotomy and healing of chronic fissure-in-ano. |
|
Scientific Title of Study
|
An open-label double-arm clinical study to evaluate the effect of Agnikarma using Panchaloha shalaka in comparison with Diathermy in
partial internal sphincterotomy and healing of 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 Keerthi M R |
| Designation |
PG Scholar |
| Affiliation |
Amrita Vishwa Vidyapeetham |
| Address |
Department of Shalyatantra (surgery)
Amrita School of Ayurveda Vallikkavu
Kollam
Kollam
KERALA
690525
India |
| Phone |
6238727648 |
| Fax |
|
| Email |
drkeerthimangalathu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Vinayan |
| Designation |
Associate Professor |
| Affiliation |
Amrita Vishwa Vidyapeetham |
| Address |
Department of Shalyatantra (surgery)
Amrita School of Ayurveda Vallikkavu
Kollam
Kollam
KERALA
690525
India |
| Phone |
9447712392 |
| Fax |
|
| Email |
shyamvinayan@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Vinayan |
| Designation |
Associate Professor |
| Affiliation |
Amrita Vishwa Vidyapeetham |
| Address |
Department of Shalyatantra (surgery)
Amrita School of Ayurveda Vallikkavu
Kollam
Kollam
KERALA
690525
India |
| Phone |
9447712392 |
| Fax |
|
| Email |
shyamvinayan@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Amritapuri Campus, Vallickavu, Kollam, Kerala |
|
|
Primary Sponsor
|
| Name |
Dr Keerthi M R |
| Address |
PG Scholar
Department of Shalyatantra (surgery)
Amrita School of Ayurveda
Vallikkavu
Kollam-690525 |
| 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 Keerthi M R |
Amrita School of Ayurveda |
Department of Shalyatantra, Amrita School of Ayurveda
Amritapuri
Vallikkavu
Kollam
Kollam
KERALA |
6238727648
drkeerthimangalathu@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 |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Susruta Samhita, Procedure details: In this group agnikarm is done using monopolar Diathermy cautery set at 26W for 2 seconds in different strokes)
| | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® using Panchaloha shalaka | (Procedure Reference: Susruta Samhita, Procedure details: In this group agnikarma is done using Panchaloha shalaka set at a temperature of 350°C for about 2 seconds different strokes are given. )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients clinically diagnosed with chronic Fissure-in-Ano.
2. Irrespective of sex.
3. Age between 20yrs- 60yrs.
4. Willingness to give consent. |
|
| ExclusionCriteria |
| Details |
1. Congenital diseases of the anal canal.
2. Patients with systemic diseases like heart diseases, diabetes, carcinoma, HIV, TB, IBS,
Crohn’s disease etc.
3. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
1. Bleeding
2. Burning sensation
3. Constipation
4. Duration of pain
5. Severity of Pain
Objective parameters:
1. Healing of wound
2. Sphincter tone
3. Quality of life |
Assessment will be done on 0th day, 7th day, 14th day, 21st day, 28th day and for the Quality-of-life assessment on 0th day, 28th day and 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Quality of life |
on 60th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2022 |
| Date of Study Completion (India) |
30/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anal fissures typically arise as a tear at the anoderm with periodic anal pain and bleeding
associated with bowel movements if it is left untreated or improper treatments leads to chronic
anal fissure. In this condition, the conservative treatment will not be effective, and to get
immediate and sustained relief we must consider surgical or para-surgical management. This
can be corelated with guda parikartika which is caused by improper virechana and vasthikarma
is characterized by cutting type of pain in guda pradesha as the main symptom.
Acharya Sushruta, while describing Agnikarma, described its indication in Vrana, which is
difficult to heal and helps in preventing the recurrence of the disease.The Agnikarma is the
ayurvedic concept of transferring direct heat with the help of shalaka to produce a therapeutical
burn. The therapeutic heat enhances blood circulation to the adjacent tissues, relieves sphincter
spasm, and increases the metabolism, thus bringing about relief of symptoms.
Agnikarma with Panchaloha shalaka seems to have less scientific validation with respect to
Sphincterotomy, removing fibrosed margins, as well as in removal of slough and dead tissues.
The study is intended to provide evidence and revalidate cauterization with Panchaloha
shalaka in healing of Parikartika.
With the help of this principle, the removal of fibrosed tissue can be done by using
Panchaloha shalaka which can make specific strokes with no blood loss and compares its
efficacy with Diathermy. In this study a specially designed temperature gauged Panchaloha
shalaka measured at 350°C at an interval of 2 seconds and cauterization is done superficially
over the fibrosed tissue in one group and in another group Superficial cauterization will be
done using monopolar diathermy probe set to coagulation mode at 26W for 2 seconds in
different strokes so that the effect reaches the fibrosed tissue.
In this study, 30 patients irrespective of sex, with age limit of 20 to 60 years, satisfying the
inclusion criteria will be recruited. The assessments will be done for duration and severity of
pain, burning sensation, bleeding, healing of wound, sphincter tone and constipation on 0th day,
7
th day, 14th day, 21st day and 28th day. Quality of life on 0th, 28th and 60th days. Wilcoxon
signed rank test and Man Whitney U test will be used for statistical analysis |