CTRI Number |
CTRI/2022/05/042828 [Registered on: 26/05/2022] Trial Registered Prospectively |
Last Modified On: |
25/05/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Study conducted to see the effect of Gandhaka Druti Pichu and Yastimadhu Taila Pichu in Fissure. |
Scientific Title of Study
|
“A Comparative Clinical Study to evaluate the efficacy of Gandhaka Druti Pichu and Yastimadhu Taila Pichu in the management of Parikartika with special reference to Acute 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 Mahalaxmi Bilagi |
Designation |
MS PG Scholar Shalyatantra |
Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka |
Address |
Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus
Bagalkot KARNATAKA 587101 India |
Phone |
9902527344 |
Fax |
|
Email |
mahalaxmibilagi9845@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M M Salimath |
Designation |
Principal and Professor |
Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka |
Address |
Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus
Bagalkot KARNATAKA 587101 India |
Phone |
9845010950 |
Fax |
|
Email |
dr_mahantesh@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr M M Salimath |
Designation |
Principal and Professor |
Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka |
Address |
Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus
Bagalkot KARNATAKA 587101 India |
Phone |
9845010950 |
Fax |
|
Email |
dr_mahantesh@yahoo.com |
|
Source of Monetary or Material Support
|
BVVS Ayurved Medical College and Hospital, Bagalkot, KArnataka - 587101 |
|
Primary Sponsor
|
Name |
BVVS Ayurved Medical College and Hospital |
Address |
BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot, Karnataka-587101 |
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 Mahalaxmi Bilagi |
BVVS Ayurved Medical College and Hospital |
Shalyatantra OPD
Room No: 03
BVVS Ayurved Medical College and Hospital Bagalkot KARNATAKA |
9902527344
mahalaxmibilagi9845@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | Guda Pichu | (Procedure Reference: Su.Chi1/40, Procedure details: Patient will be educated about the procedure.
Patient will be adviced to clean the perianal region.Then after taking the comfortable position, adviced to insert the medicated Pichu in the anal region, it should be removed after 6 hours.
The patient is advised to do the same procedure twice a day for 7 days.
) (1) Medicine Name: Gandhaka Druti, Reference: RRS 3/32-33, Route: Topical, Dosage Form: Taila, Dose: 0.5(ml), Frequency: bd, Duration: 7 Days | 2 | Comparator Arm | Procedure | - | Guda Pichu | (Procedure Reference: Su.Chi1/40, Procedure details: Patient will be educated about the procedure.
Patient will be adviced to clean the perianal region.Then after taking the comfortable position, adviced to insert the medicated Pichu in the anal region, it should be removed after 6 hours.
The patient is advised to do the same procedure twice a day for 7 days.
) (1) Medicine Name: Yastimadhu Taila, Reference: Su.Chi.34/16, Route: Topical, Dosage Form: Taila, Dose: 0.5(ml), Frequency: bd, Duration: 7 Days |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients diagnosed with Parikartika (acute
fissure- in-ano)
2.Patients with diabetes and hypertension which are
under control |
|
ExclusionCriteria |
Details |
1. Patients diagnosed with other co-existing Ano
rectal diseases.
2. Fissure in ano due to systemic disorders.
3. Patients suffering from infectious diseases.
4. Patients of chronic fissure in ano with
sentinel pile.
5. Pregnant women & lactating women.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in pain, burning sensation, bleeding per rectum and constipation |
15 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in the size of ulcer.
Improvement in the wound healing
|
15 Days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
31/05/2022 |
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
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mahalaxmibilagi9845@gmail.com].
- For how long will this data be available start date provided 31-05-2022 and end date provided 31-05-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
|
Parikartika is one of the most painful and commonest condition in Gudagata Vikaras affecting majority of the population in modern world. Acharya’s have explained it as one among the Vamana Virechana Vyapat and Bastivyapat. It is caused by Sthana Samshraya of vitiated Vata & Pitta Dosha’s in Gudapradesh, leading to Kartanavat Vedana and Daha in Gudapradesh. It can be correlated to fissure-in-ano based on signs and symptoms. Fissure-in-ano is an elongated ulcer in longitudinal axis of lower anal canal associated with constipation, severe pain & burning sensation during defecation and bright red bleeding. In acute type pain is so severe that, patient develops fear for defecation and this further worsens the condition. Fissure-in-ano occurs most commonly in midline posteriorly, in males usually posteriorly 95%, anteriorly 5%, & in females posteriorly 80%, & anteriorly 20%. About 30–40% of the population suffers from proctologic pathologies at least once in their lives, in that anal fissure comprises of 10–15%. It occurs equally in both men & women and is common in all age groups especially adults of 15-40 years. The incident is supposed to be high in one who passes hard & dry stool. In the Chikitsa of Parikartika, Acharyas have mentioned Madhura, Kashaya Rasa Sneha Yukta Dravya’s in the form of Piccha Basti, Anuvasana Basti, Pichu, Varti & Lepa, which pacifies Vata and Pitta Dosha’s. Acharya Sushrutha has mentioned Anuvasana Basti with Grithamanda & Yastimadhu Taila in Parikartika. Acharya Sushrutha has mentioned Pichu Prayoga in the context of Shashti Upakrama, in the management of Vrana. Yastimadhu Taila is having Vata-Pittahara Guna, Sheeta Veerya, which acts as Dahaprashamaka and Vranaropaka, hence it is taken as standard drug by previous research works done. Gandhaka Druti is mentioned in Rasa Ratna Samucchaya in the context of Uparasas, It is Taila obtained of Gandhaka, which acts as Vedanasthapaka and Vranaropaka, so it has been selected in the treatment of Parikartika. Hence the present study is under taken to evaluate and compare the efficacy of Gandhaka Druti Pichu and Yastimadhu Taila Pichu in the management of Parikartika w.s.r to Acute Fissure-in-Ano. |