| CTRI Number |
CTRI/2025/05/087335 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of prapaundarikadi taila matrabasti and darvi taila matrabasti with dilatation by gradual anal dilator in moderate to severe sphincteric spasm in the management of parikartika w.s.r.to Fissure in ano. |
|
Scientific Title of Study
|
Comparative clinical trial to evaluate the efficacy of prapaundarikadi taila matrabasti and darvi taila matrabasti with dilatation by gradual anal dilator in moderate to severe sphincteric spasm 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 |
Dr Nitin Vishnudas Dudhate |
| Designation |
PG Scholar M.S. Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College, Babhulgaon, Yeola |
| Address |
Matoshri Asarabai Darade Ayurved Hospital,Ground floor,OPD No 04-05,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon,Tal-Yeola,Dist-Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
8788640192 |
| Fax |
|
| Email |
nitindudhate98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj L Sonaje |
| Designation |
HOD and Professor, Department of Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College, Babhulgaon, Yeola |
| Address |
Matoshri Asarabai Darade Ayurved Hospital,Ground floor,OPD No 04-05,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon,Tal-Yeola,Dist-Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
9423932283 |
| Fax |
|
| Email |
manojsonaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Vishnudas Dudhate |
| Designation |
PG Scholar M.S. Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved College, Babhulgaon, Yeola |
| Address |
Matoshri Asarabai Darade Ayurved Hospital,Ground floor,OPD No 04-05,Matoshri Asarabai Darade Ayurved college,SND Campus,Babhulgaon,Tal-Yeola,Dist-Nashik
Nil
Nashik
MAHARASHTRA
423401
India |
| Phone |
8788640192 |
| Fax |
|
| Email |
nitindudhate98@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 |
Department of Shalyatantra,GROUND floor,OPD NO 04/05, Matoshri Asarabai Darade Ayurved College and Matoshri Asarabai darade hospital,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 |
| Dr Nitin Vishnudas Dudhate |
Matoshri Asarabai Darade Hospital Babhulgaon Yeola |
Department of Shalyatantra,Ground floor,OPD no 04/05,Matoshri Asarabai Darade Hospital,SND campus,Babhulgaon,Yeola 423401
Nashik
MAHARASHTRA |
8788640192
nitindudhate98@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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Comparator Agent |
Darvi Taila Matrabasti with Dilatation by gradual anal dilator |
Dilatation by gradual anal dilator with 5% lignocaine jelly
Anal dilator no- 1 to 7
Size- 4mm to 10mm
Duration- 7 days
Matrabasti
Drug name- Darvi Taila
Referance- Charak chikitsa 25 shloka 93
Route- Anal canal
Dosage form- Taila
Dose- 60ml
Frequency- OD
Duration- 7 days
|
| Intervention |
Prapaundarikadi Taila Matrabasti with Dilatation by gradual anal dilator |
Dilatation by gradual anal dilator with 5% lignicaine jelly
Anal dilator no- 1 to 7
Size- 4mm to 10mm
Duration- 7 days
Matrabasti
Drug name- Prapaundarikadi Taila
Referance- Charak chikitsa 25 shloka 92
Route- Anal canal
Dosage form- Taila
Dose- 60ml
Frequency- OD
Duration- 7 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 years to 60 years were selected.
2. Patients presenting with classical signs and symptoms like Pain, Burning Defecation, per rectal bleeding,itching,constipation ,Moderate to severe anal sphincteric spasm at anal region.
3. Patients will be selected irrespective of gender, religion, socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1.patients with disease like ,ulcerative colitis,crohns disease,syphilis.
2.patients with co-morbidities like Hypertention, diabetes mellitus,HIV,hepatitis.
3.Pregnant and lactating women .
4.Patients is suffering from fissure in Ano with no sphincteric Spasm.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
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. Burning Defecation
3. Bleeding per anum
4. Itching
5. Sphincteric Spasm
6. Wound Healing
7. Tenderness |
0th,7th,14th,21st,28th,35th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
25/05/2025 |
| 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 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
|
Fissure in Ano is the disease which causes considerable discomfort and pain occure most commonly in the midline posterior of anal canal. In Ayurvedic literature "Parikartika" has been mentioned by Aacharya Sushrut a condition characterized by cutting and burning pain around the anus, penis, umbilics and neck of bladder cessation. Parikartika is occur by influence of vata and pitta dosha, vata causes pain like cutting with a sharp instrument i.e. Scissors and pitta causes burning sensation along with inflammation. When Vata is covered with faeces, the stool is constipated, patient suffers from severe pain and passes hard stools with difficulty and evacuation is delayed. Prapaundrikadi taila is explained by Acharya Charaka in Dwivraniya Chikitsa, based on the rasapanchaka madhura, kashaya and sheeta guna it does daha prashamana and vrana Ropana. Parikartika is Vranalakshanayukta gudavikara. Charaka mentioned Darvi taila as an Vranaropaka, Kandugna, and Vatanulomaka in nature . prapaundarikadi taila Matrabasti and Darvi taila matrabasti with dilatation by gradual anal dilator by reducing pain, bleeding, inflammation, spasm and itching by keeping equilibrium of doshas and promoting wound healing . |