| CTRI Number |
CTRI/2025/03/081567 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of Yasthimadhu tail matrabasti along with lords dilattion in the management of Parikartika w.s.r.to Fissure in ano. |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the efficacy of Yashtimadhu tail matrabasti along with Lords Dilatation in the management of Parikartika w.s.r.to 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 |
DrRoshani Pukharaj Pawar |
| Designation |
PG scholar M.S.Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College,Babhulgaon,yeola |
| Address |
Department of shalyatantra,Ground floor,OPD no 4-5,Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade hospital,SND Campus,Babhulgaon,Yeola 423401
Department of shalyatantra,second floor,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon, Yeola
Nashik
MAHARASHTRA
423401
India |
| Phone |
9881470509 |
| Fax |
|
| Email |
rosspawar1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManoj L Sonaje |
| Designation |
HOD and Professor, Department of Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved college,Babhulgaon,yeola |
| Address |
Department of shalyatantra,Ground floor,OPD no 4-5,Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade hospital,SND Campus Babhulgaon,Yeola 423401
Department of shalyatantra,second floor,Matoshri Asarabai Darade Ayurved college,SND campus,Babhulgaon, Yeola
Nashik
MAHARASHTRA
423401
India |
| Phone |
9423932283 |
| Fax |
|
| Email |
manojsonaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRoshani Pukharaj Pawar |
| Designation |
PG scholar M.S.Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College,Babhulgaon,yeola |
| Address |
Department of shalyatantra,Ground floor,OPD no 4-5,Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade hospital,SND Campus,Babhulgaon,Yeola 423401
Department of shalyatantra,second floor,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon, Yeola
Nashik
MAHARASHTRA
423401
India |
| Phone |
9881470509 |
| Fax |
|
| Email |
rosspawar1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshri Asarabai Darade Ayurved College affiliated with Matoshri Asarabai Darade Hospital,SND Campus,Babhulgaon,Yeola-423401 |
|
|
Primary Sponsor
|
| Name |
Matoshri Asarabai Darade Ayurved college ,Babhulgaon,Yeola |
| Address |
Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade hospital, Department of shalyatantra,Ground floor,OPD no 4-5 ,SND Campus,Babhulgaon,Yeola 423401 |
| 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 |
| DrRoshani Pukharaj Pawar |
Matoshri Asarabai Darade Hospital,Babhulgaon,Yeola |
Department of Shalyatantra,Ground floor,OPD no.4-5,Matoshri Asarabai Darade Hospital,SND Campus,Babhulgaon,Yeola-423401
Nashik
MAHARASHTRA |
9881470509
rosspawar1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical comittee Matoshri Asarabai Darade Ayurved College,Babhulgaon ,Yeola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Lords dilatation in fissure in ano | Lords dilatation is the manual dilatation of anus under Spinal anesthesia with relaxation using four fingers of each hand to cause vigorous stretching of the anal canal to break the circular constricting band in the wall of the anorectum. | | 2 | Intervention Arm | Procedure | - | बस्तिकर्म मात्राबस्ति | (Procedure Reference: Sushrut chikitsa adhyaya 34 shloka 16, Procedure details: after successful lords dilataion matrabsti will be given for 7 days )
(1) Medicine Name: Yashtimadhu siddha til tail, Reference: sushrut chikitsa adhyaya 34 shloka 16, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 20 years to 50 years were selected.
2.Patients presenting with classical signs and symptoms as follows :
a)Pain. b)Burning sensation. c)bleeding per rectal. d)Itching. e)constipation f)Moderate anal sphincteric spasm at anal region with acute or chronic form with or without Sentinel tag will be selected from OPD and IPD of our hospital.
3.Patients will be selected irrespective of Gender, Religion, Occupation ,Socio-economic status, Severity of disease.
|
|
| ExclusionCriteria |
| Details |
1.Patients with K/C/O carcinoma of rectum, Condiloma, ulcerative colitis, veneral diseases, crohn’s disease, HIV & HBsAg positive patients, diabetes, bleeding disorder and diarrhoea, dysentery, severe proctitis.
2. Patients suffering from fissure in ano due to any secondary cause such as syphilitic ulcer and tubercular ulcer.
3. Patient which is suffering from more than 2 anorectal diseases will be excluded.
4. Pregnant and lactating women.
5. Patient is suffering from Fissure in ano with no sphincteric Spasm.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
the Parameters will be noted down before and after treatment.
The patient will be diagnosed based on symptoms of Parikartika Explained in Ayurvedic and Modern texts.
1.Pain
2.Bleeding per Rectal
3.Burning sensation
4.Itching
5.Sphincter Spasm
6.Wound assessment
7.Tenderness
|
1st,3rd,7th,14th,21th,28th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nill |
Nill |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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 Yet Recruiting |
| 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
|
Fissure in ano is the disease which causes considerable discomfort and pain occur most commonly in the midline posterior of anal canal and characterised by excruciating pain during and defecation and drop by drop bleeding per anus with spasm of anal sphincter. Parikartika occurs by influence of vata and pitta doshas.vata causes pain like cutting with sharp instrument and pitta causes burning sensation along with inflammation.when vata affects faeces,the stool is constipated and evacuation is delayed. Amongst al ancient authors focused on basti chikitsa while treating the disease parikartika. Non invasion interventions in the management of any disorder is better than invasive or surgical measures.As per previous work done Lord’s Anal dilatation with lateral sphincterotomy are an invasive form of treatment modality.Any intervention which is non invasive, efficient,cost effective,easy to administer may become an popular medicine or modality form so yashtimadhu tail matrabasti has been selected for study. |