| CTRI Number |
CTRI/2025/08/093205 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Lajjalu Taila Pichu and Yashtimadhu Taila Pichu in the Treatment for Pain Relief and Healing in Acute Fissure-in-Ano (Parikartika) in Adults |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Lajjalu Taila Pichu versus Yashtimadhu Taila Pichu in the Management of Parikartika W.S.R. 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 Dinesh B Varvadiya |
| Designation |
Shalyatantra Post Graduate Scholar |
| Affiliation |
Shri Shivayogeeshwar Rural Ayurvedic Medical College |
| Address |
Department of Shalya Tantra Division of Proctology Room No 35
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital Inchal Saundatti Taluk, Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA
591102
India |
| Phone |
9714593073 |
| Fax |
|
| Email |
dr.dbpatel86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K H Pachchinavar |
| Designation |
Shalya Tantra Professor |
| Affiliation |
Shri Shivayogeeshwar Rural Ayurvedic Medical College |
| Address |
Department of Shalya Tantra Division of Proctology Room No 35
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital Inchal Saundatti Taluk, Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA
591102
India |
| Phone |
9880499597 |
| Fax |
|
| Email |
kubendra.pacchinnavar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh B Varvadiya |
| Designation |
Shalyatantra Post Graduate Scholar |
| Affiliation |
Shri Shivayogeeshwar Rural Ayurvedic Medical College |
| Address |
Department of Shalya Tantra Division of Proctology Room No 35
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital Inchal Saundatti Taluk Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA
591102
India |
| Phone |
9714593073 |
| Fax |
|
| Email |
dr.dbpatel86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Shivayogeeshwar Rural Ayurvedic Medical College Shalya Tantra Department Inchal Savdatti TQ Belagavi Dist Karnataka India Pincode 591102 |
|
|
Primary Sponsor
|
| Name |
Dr Dinesh B Varvadiya |
| Address |
Shri Shivayogeeshwar Rural Ayurvedic Medical College Shalya Tantra Department Inchal Savdatti TQ Belagavi Dist Karnataka India Pincode 591102 |
| Type of Sponsor |
Other [Self Dr Dinesh B Varvadiya] |
|
|
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 Dinesh B Varvadiya |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital, Inchal |
Shalya Tantra Department Division of Proctology Room no 35 Inchal Savdatti TQ Belagavi Dist Karnataka India Pincode 591102
Belgaum
KARNATAKA |
9714593073
dr.dbpatel86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Shivayogeeshwar Rural Ayurvedic Medical College Institutional Ethical Clearance Committee |
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, पिचु | (Procedure Reference: Raj Nighantu Samhita ,parpati varga of pandit Narhari edited with dravyagunaprakashika hindi commentary- by indradev Tripathi , shloka ; 103-106 , page no -125, Procedure details: Taila Pichu / 20 min Daily for 10 Days)
(1) Medicine Name: Lajjalu tailu Pichu, Reference: Raj Nighantu Samhita ,parpati varga of pandit Narhari edited with dravyagunaprakashika hindi commentary- by indradev Tripathi , shloka ; 103-106 , page no -125, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Sushruta Samhita Nibandh sangraha commentary by yadavaji trikamaji acharya , chaukhamba series edition 2008 Varanasi, sutrasthan 5/42, page no – 23, Procedure details: Yashtimadhu Taila Pichu)
(1) Medicine Name: Yashtimadhu Taila, Reference: Acharya sushruta, sushruta Samhita with Nibandh sangraha, chikitsasthana ch-34,shloka-16; editor- Vasant patil & Rajeswari N.M. Varanasi , chaukhamba publication, pg- 576, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of religion, occupation, socio-economic status.
Patients who are clinically diagnosed as a case of parikartika.
Patients who are k/c/o Hypertension, Diabetes Mellitus only which are under control limit will also be considered for the study |
|
| ExclusionCriteria |
| Details |
Patients who are aged below 20 years and more than 60 years.
Patients of Parikartika secondary to other diseases like rectal carcinoma , ulcerative colitis, crohn’s disease, tuberculosis etc.
Patients with uncontrolled hypertension and diabetes.
Patients who are diagnosed as HIV +ve, HbsAg +ve will also be excluded from the study. |
|
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Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing of Fissure
Reduction in Bleeding during defecation
|
10 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Releavinf spincter spasm
Reduction in pain |
20 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A)TYPE OF STUDY: A comparative clinical Interventional study B) TREATMENT GROUP: 60 diagnosed patients of Parikartika based on clinical evaluation of lakshanas will be selected and divided into 2 equal groups, namely Group A( Trial group) and Group B (Control Group) of 30 each. C) DURATION OF TREATMENT: Group A (Trial group): Number of patients 30 Procedure: Local application of lajjalu taila pichu once daily. Duration: 10 days Group B (control group): Number of patients 30 Procedure: Local application of yashtimadhu taila pichu once daily. Duration: 10 days Clinical features are recorded before the treatment i.e., on day zero. Changes with the treatment will be observed on 10th day, as per the proforma of the case sheet, prepared for the study D) SAMPLE SIZE: 60 patients fulfilling the diagnostic and inclusion criteria of either sex will be selected for the study. E) DIAGNOSTIC CRITERIA: Diagnosis will be made based on clinical evaluation i.e., lakshanas like kartanavat shoola (cutting type of pain), daha (burning sensation), kandu (itching), shonita srava (bleeding).
F) ASSESSMENT CRITERIA: Assessment will be done by giving specific gradation to subjective and objective criteria. Subjective criteria : | Gradation | Pain | P/R bleeding during defecation | Ulcer in ano | | 0 | no pain | nil | no ulcer | | 1 | pain at the time of defecation and subside within 30 minutes | streak of blood over the surface of the stool | ulcer with healthy granulation tissue | | 2 | pain at the time of defecation and subside more than 30 minutes to less than 1 hour | dropwise bleeding during the passage of stool (5-6 drops) | presence of ulcer with indurated margins | | 3 | continuous unbearable pain at the time of defecation which persist more than 1 hour | moderate bleeding during the passage of stool (20-25 drops) | presence of ulcer with indurated margins and slough |
Objective criteria :
a) Assessment of sphincteric spasm. Assessment of objective criteria will be made before and after treatment on the basis of gradation. Sphincteric spasm 0 = Normal (No spasm of anal sphincter) 1 = Mild (Spasm anal sphincter present) 2 = Moderate (Due spasm of anal sphincter) 3 = Severe (Per rectal examination not possible due to severe spasm of anal sphincter) b) Size of ulcer ( Fissure bed ) Assessment of objective criteria will be made before and after treatment on the basis of gradation. | Gradation | Size of ulcer | | 1 | Below 5 mm | | 2 | 5 mm to 10 mm | | 3 | Above 10 mm | Overall assessment of treatment | Sr.no | Result | Assessment | | 1 | Cured | Relief in pain and discomfort within 10 days and wound healing within 30 days | | 2 | Moderate improvement | Relief in pain but mild discomfort within 11-20 days and wound healing within 30 days | | 3 | Mild improvement | Mild relief in pain and discomfort within 21-30 days and wound healing within 30 days | | 4 | No relief | No relief in pain and discomfort till 30 days | FOLLOW UP : Patient will be advised for follow up once on 10th day for 30 days. Clinical observations will be recorded systematically. ADVISE : Laghu, anabhishyandi aahara. intake of fluids. Avoid ruksha diet, avoid junk and spicy foods, and beverages. G). STATISTICAL ANALYSIS : The data will be collected and statistically analyzed using appropriate tests by consulting a statistician. |