| CTRI Number |
CTRI/2024/10/075068 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to compare the efficacy of Manjistha Narikel oil gauze and Lignocaine 2% gel as a local intervention in Fissure in ano. |
|
Scientific Title of Study
|
A randomised controlled clinical trial of Manjistha Narikel tel pichu and Lignocaine 2 percent gel as a local intervention in Parikartika (Fissure in ano). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayur Bharat Jadhav |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra, 2nd floor, Tilak Ayurved Mahavidyalaya Rasta Peth 583/2 Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
09511624702 |
| Fax |
|
| Email |
mayur.jadhav3112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanraj B Gaikwad |
| Designation |
Associate Professor Shalyatantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9422342048 |
| Fax |
|
| Email |
draj.gaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayur Bharat Jadhav |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
09511624702 |
| Fax |
|
| Email |
mayur.jadhav3112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011,
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 Mayur Bharat Jadhav |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA |
09511624702
mayur.jadhav3112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Lignocaine 2% gel | Lignocaine Hydrochloride gel works by restricting the sensation of pain by acting on peripheral nerves in the body. Lignocaine Hydrochloride Gel is used for pain caused by anal or rectal problems, mouth ulcers, denture irritation, as local anesthetic before minor surgeries, numbing agent and other conditions. | | 2 | Intervention Arm | Procedure | - | picu, पिचॠ| (Procedure Reference: Ashtanghridaya , Procedure details: Pichu is a palliative Treatment for ailments of the whole body. During this treatment, a long, thick layer of cotton wool soaked with warm medicated oil is applied over the affected area. The oil is replaced periodically to keep it warm and therapeutic.)
(1) Medicine Name: Manjistha-Narikel tel, Reference: Kaiyadev Nighantu, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 20 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed Patients of fissure in ano(Parikartika).
Patients among the age group 18 to 60 years, irrespective of gender and socio-economic status |
|
| ExclusionCriteria |
| Details |
Patient with uncontrolled systemic disease like diabetes and hypertension willbe excluded.
Patient with known case of Ca rectum will be excluded.
Severely immuno compromised Patients.
Patients having Parikartika,secondary to ulcerative colitis, Syphilis, T.B. will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Gudagat Shool, Raktstrava, Kandu. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Gudagat Shool, Raktstrava, Kandu, Anal Sphincter spasm and anal ulcer |
20 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/10/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be intervened by the treatment of Manjistha Narikel Tel and Lignocaine 2% gel to group A and group B respectively. The efficacy of the therapy will be assessed on the
basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity
of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of
each symptom will be calculated before treatment, after treatment and after follow up. The effect of
treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading
and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring
method |