| CTRI Number |
CTRI/2025/07/090552 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Relieving symptoms of Parikartika ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Manegment of Fissure with Yastimadhu Panchavalkal Ghrit Suppositor
|
|
Scientific Title of Study
|
Use of Yastimadhu Panchavalkal Ghrut suppository in relieving symptoms of Parikartika (Fissure in Ano) in conservative management of 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 Pandurang Eknathrao Dhage |
| Designation |
Pg Scholar MS Shalyatantra |
| Affiliation |
DMM Ayurved Mahavidyalaya Yavatmal |
| Address |
Department of Shalyatantra Dayabhai Maoji Majithiya Ayurved Mahavidyalaya Arni road Shivaji Nagar Yavatmal 445001
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9082176479 |
| Fax |
|
| Email |
dhagepandurang792@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxminiwas R Soni |
| Designation |
HOD and Professor, Department of Shalyatantra |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and LK Ayurved Rugnalaya, Department of Shalyatantra, OPD no. 05 Shivaji Nagar Arni road Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9890578425 |
| Fax |
|
| Email |
lrsoni10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxminiwas R Soni |
| Designation |
HOD and Professor, Department of Shalyatantra |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and LK Ayurved Rugnalaya, Department of Shalyatantra, OPD no. 05 Shivaji Nagar Arni road Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9890578425 |
| Fax |
|
| Email |
lrsoni10@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMM Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya Shivaji nagar, Arni road Yavatmal 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya Yavatmal |
| Address |
DMM Ayurved Mahavidyalaya and LK Ayurved Rugnalaya opd no.5 Shalyatantra department Shivaji Nagar Arni road Yavatmal 445001 |
| Type of Sponsor |
Other [Government Aided 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 Pandurang Eknathrao Dhage |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and LK Ayurved Rugnalaya Yavatmal |
Shalyatantra department OPD no.05 and IPD no 25, 26 LK Ayurved Rugnalaya Yavatmal
Yavatmal
MAHARASHTRA |
9082176479
dhagepandurang792@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, D.M.M. Ayurved Mahavidyalaya, Yavatmal |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu Panchavalkal Ghrut Suppository, Reference: 1 Bhavprakashnighantu by Bhisagratna Pandit Sri. Brahma Sankara Misra 2 Rajnighantu by Dr. Indradev Tripathi 3 Dravyagunavidnyan by Dr. A. P. Deshpande, Dr. R. R. Jawalgekar, Dr. S. Ranade, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1.82(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from Fissure in Ano (acute or chronic) in which surgery is not indicated.
2.Patients irrespective of caste, religion, sex, economic status. 3. Patients who can give written consent and regular follow up.
4.Patients between age group 18 to 60 years.
5.Patients suffered from Parikartika with controlled Diabetes mellitus and controlled Hypertension. |
|
| ExclusionCriteria |
| Details |
1.Fissure in Ano associated with inflamed sentinel tag, fistula in Ano, hemorrhoids, anorectal abscess, ulcerative colitis, Crohns disease, CA rectum, rectum prolapse and rectal polyp. 2.HIV, HBsAg positive patient. 3.Sexually transmitted diseases. 4. Lactating and breastfeeding womens. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters will be noted down before and after treatment
Patients will be diagnosed based on symptoms of Parikartika (Fissure in Ano) explained in Ayurvedic and Modern texts
1 Pain
2 Bleeding
3 Ulcer
4 Itching
|
1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 9th, 11th, 13th, 15th, 18th, 21st, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Cured –70-100% relief in signs & symptoms.
2) Markedly improved-50-70% relief in signs & symptoms.
3)Improved-30-50% relief in signs & symptoms.
4) Unchanged- Less than 30% relief in signs and symptoms. |
1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 9th, 11th, 13th, 15th, 18th, 21st, 28th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
19/07/2025 |
| 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
|
Parikartika (Fissure in Ano) is most common among anorectal diseases. According to Ayurveda when a person of Kshinbala, Mrudukoshta, Mandagni or Ruksha prakruti takes Ati-tikshna, Ati-ushna, Ati-lawan or Ati-ruksha medicine, his Pitta and Vata gets polluted due to which a phenomenon called ’Parikartika’ occurs. Parikartika is associated with symptoms like burning pain, bleeding, ulcer and sometimes pruritis. Yastimadhu Panchavalkal Ghrut suppository contains Yastimadhu and Panchavalkal. Yastimadhu is Madhura rasa pradhan Sheeta virya and act as a Pitta,Rakta and Vata shamaka. It helps in vranaropana, vednashamana, shotha shamana. Yastimadhu’s active compounds reduce inflammation in the anal region, alleviating pain and promoting healing. In Panchavalkal 1) Vat helps in dahashaman, wound healing and having anti-inflammatory properties. 2) Udumbar helps in wound healing. 3) Ashvathha helps in raktavikar and dahshaman. 4) Plskha heps in raktaj vikar. 5) Vetas works as vranashodhka. So, I am using Yastimadhu Panchavalkal Ghrut suppository in relieving symptoms of Parikrtika [Fissure in Ano] in conservative management of Fissure in Ano. Follow up will be taken on 1st,2nd,3rd,4th,5th,6th,7th,9th,11th,13th, 15th,18th, 21st, and 28th day. |