| CTRI Number |
CTRI/2024/07/071129 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| 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 effect of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute Fissure-in-Ano.†|
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to evaluate the efficacy of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute 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 Pravin Birajadar |
| Designation |
PG Scholar |
| Affiliation |
BVVS Ayurved Medical College and Hospital |
| Address |
Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus
Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9960516461 |
| Fax |
|
| Email |
pravinbirajadar2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital |
| Address |
Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus
Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital |
| Address |
Department of PG Studies in Shalyatantra BVVS Ayurved Medical College and Hospital BVVS Campus
Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.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 Pravin Birajadar |
BVVS Ayurved Medical College and Hospital Bagalkot 587101 |
Shalyatantra OPD
Room No 03
BVVS Ayurved Medical
College and Hospital
Bagalkot
Bagalkot KARNATAKA |
9960516461
pravinbirajadar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BVVS Ayurveda 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 | - | picu, पिचॠ| (Procedure Reference: Baishajaratnavali, Procedure details: Purvakarma-
1 Informed consent will be taken.
2 Collection of all the materials required for the procedure.
3 Patient will be advised for sitz bath with luke warm water for 15 minutes.
4 Patient will be asked to lie comfortably in the lithotomy position on the examination table
5 The Pichu will be soaked in Kajjalikodaya Malahara.
Pradhana karma-
1 Patient will be asked to relax, take deep breaths and strain, then gently Pichu will be inserted into the anal canal.
Paschata karma-
1 Patient will be advised to remove the Pichu after 3 hrs.
2 Patient will be advised to follow Pathya.
) (1) Medicine Name: Triphala, Reference: Astanga hridaya uttara tantra 13th chapter 14,15 sloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: hs, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | picu, पिचॠ| (Procedure Reference: Astanga hridaya , Procedure details: Purvakarma-
1 Informed consent will be taken.
2 Collection of all the materials required for the procedure.
3 Patient will be advised for sitz bath with luke warm water for 15 minutes.
4 Patient will be asked to lie comfortably in the lithotomy position on the examination table
5 The Pichu will be soaked in Jatyadi Ghritha
Pradhana karma-
1 Patient will be asked to relax, take deep breaths and strain, then gently Pichu will be inserted into the anal canal.
Paschata karma-
1 Patient will be advised to remove the Pichu after 3 hrs.
2 Patient will be advised to follow Pathya.
) (1) Medicine Name: Triphala , Reference: Astanga hridaya ,Uttara tantra 13th chapter 14,15 sloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: hs, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients diagnosed with parikartika are selected.
2.Patients aged between 18 – 60 years of either gender.
|
|
| ExclusionCriteria |
| Details |
1 Patients diagnosed with other co-existing Ano rectal diseases, like hemorrhoids, fistula-in-ano, Ca rectum etc.
2 Patients of chronic fissure -in- ano with sentinel pile.
3 Patients with uncontrolled diabetes and hypertension.
4 Fissure-in-ano due to systemic disorders like ulcerative colitis, Crohns disease etc.
5 Patients suffering from infectious diseases, like RVD, Syphilis, HbsAg etc.
|
|
|
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
|
18 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of ulcer
|
18 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)
|
12/08/2024 |
| 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
|
Parikartika is one among the ano-rectal disorders and is one of the complications of Basti and Virechana Karma as mentioned in classics. Parikartika is characterized by Kartanavat and Chedanavat Shoola, Daha in Guda. associated with Vibhanda, Anilasanga and Nabheradhorujam. It is caused by Sthana Samshraya of vitiated Vata and Pitta Doshas in Gudapradesha. It can be correlated with fissure-in-ano of the contemporary science. Anal fissure is longitudinal split in anoderm of the distal anal canal, which extends from the anal verge proximally towards but not beyond the dentate line.It is characterized by severe pain and burning sensation during and after defecation, severe constipation, and there is a drop of blood or streak of fresh blood on stool. Fissure-in-ano occurs most commonly in midline posteriorly, in males usually posteriorly 95%, anteriorly 5%, and in females posteriorly 80%, and 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 and women and is common in all age group especially age group of 15-40 years. The incident is supposed to be high in one who passes hard and dry stool. The line of management in contemporary science is said to be conservative treatment and surgical intervention. The conservative treatment includes analgesics, stool softeners, soothing ointments and anal dilatation where as surgical intervention includes Lord’s dilation, posterior fissurectomy and lateral anal sphincterotomy. In the Chikitsa of Parikartika, Acharyas have mentioned Madhura, Kashaya Rasa, Sneha Yukta Dravyas in the form of Pichu, Varti and Lepa which pacifies Vata and Pitta Doshas. Parikartika is considered as Sadyovrana, Acharya Sushruta has mentioned Pichu Prayoga in the context of Shashti Upakrama in the management of Vrana. Pichu is a treatment modality in which drug delivery increases by the contact time between the tissue and drug and as it increases the bioavailability of drug, Hence there will be early reduction of symptoms and ulcer takes less time to heal. Kajjalikodaya Malahara is mentioned in Bhaishajaratnavali is having properties like Lekhana, Krimigna, Shodhana and Ropana, It acts as Vranashodhaka and Vranaropaka, so it has been selected in the treatment of Parikartika. Jatyadi Ghrita is having properties like Tridoshahara, Lekhana, Shodhana and Ropana, which acts as Vedanahara, Vranashodhaka and Vranaropaka. Hence the present study is undertaken to evaluate and compare the efficacy of Kajjalikodaya Malahara Pichu and Jatyadi Ghrita Pichu in the management of Parikartika with special reference to Acute Fissure-in-Ano. |