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CTRI Number  CTRI/2026/02/103655 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ayurvedic management of parikartika with Ambhashtadi taila matrabasti  
Scientific Title of Study   A Randomized controlled clinical study to evaluate the efficacy of Ambhashtadi taila matra basti and Jatyadi taila matra basti in the management of Parikartika(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 Shivukumar  
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231 
Address  OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231
OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231
Koppal
KARNATAKA
583231
India 
Phone  8497810622  
Fax    
Email  shivukumartotad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahantesh M Salimath 
Designation  Professor , Head of the Department 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231 
Address  OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231
OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231
Koppal
KARNATAKA
583231
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahantesh M Salimath 
Designation  Professor , Head of the Department 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231 
Address  OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231
OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231
Koppal
KARNATAKA
583231
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Source of Monetary or Material Support  
OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231 
 
Primary Sponsor  
Name  Dr Shivukumar 
Address  OPD No 16,Department of Shalya Tantra. Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivukumar  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal-583231.  OPD No 16,Department of Shalya Tantra.
Koppal
KARNATAKA 		 8497810622

shivukumartotad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe SJGAMC &H Koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ambhashtadi Taila, Reference: Sushruta Samhita, Sutrasthana, 38th Chapter, Dravya sangrahaniya adhyaya,46th Shloka., Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Jatyadi Taila, Reference: Sushruta Samhita Chikitsa sthana 34th chapter,16th Shloka,, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
1.Patients of either sex.
2.Patients with age group between 18–40 years.
3.Patients presenting with complaints of Acute Fissure-in-ano like Constipation, Painful and Burning defecation and Streaks of blood or Drops of blood in stool.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
1.Patient diagnosed with chronic Fissure-in-ano
2.Fissure-in-ano Secondary to ulcerative Colitis, Crohn’s disease, Malignancy and associated with Haemorrhoids and Fistula-in-Ano.
3.Systemic disorders like Diabetes and Hypertension.
4.Immunosuppressive disorders like Tuberculosis, HIV, HCV and HbsAG Positive. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ambhashtadi Taila matrabasthi is significantly more effective than the jatyadi taila matrabasti in the management of parikarthika.  7 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
Ambhashtadi taila having properties of vranaropana,wholesome for pittadosha,Dahaprashamana. It cures cut wounds and reduces pain and burning sensation and constipation.  7 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   Phase 3 
Date of First Enrollment (India)   21/02/2026 
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="4"
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 Longitudinal tear in the lower end of anal canal. It is the most painful condition affecting the anal region.

      Fissure-in–Ano occurs most commonly in posterior midline. In males usually posteriorly Ninghty Five Perecent, anteriorly Five Percent & in females posteriorly Eighty Percent, anteriorly Twenty Percent. About Thirty to Fourty Percent of the population suffers from proctological pathologies, In that Anal Fissure comprises of Ten to Fifteen Percent.

       Research statistic shows the annual incidence of Parikartika (Acute Fissure-in-Ano) is 0.11 Percent. It occurs equally in both men and women occurs in all age groups especially adults of 18– 40 years. In Present day sedentary lifestyle, improper food habits and unhygienic condition leads to Fissure-in-Ano. Anal fissures occur more commonly in posterior midline because of relative Ischemia. Clinical features of Acute Fissure-in-ano are Severe pain during and after defaecation, burning in nature lasting for about ½ to 1 hour because of which defaecation is postponed. Severe Constipation is present. And Stools are hard, pellet like and there is a drop of blood or streaks of fresh blood.

       In Chikitsa of Parikartika (Acute Fissure-in-Ano), Acharya Charaka has mentioned Madhura, Kashaya rasayuktha dravya’s in the form of Piccha Basti, Pichu and Lepa. Acharya Sharangadhara has mentioned Anuvasana Basti in Parikartika. Matrabasti is a type of Anuvasana Basti, So it is considered for the study as a treatment modality.

      Ambhashtadi gana dravyas are mentioned in Sushruta Samhita having properties of vranaropana, wholesome for pitta dosha, and also dahaprashamana in nature. Here Ambhashtadi taila is used in the matrbasti to treat Parikartika, which is cost effective, drugs are easily available. Hence in this study an effort is made to evaluate the efficacy of Ambhashtadi taila matrabasti in the management of Parikartika (Acute Fissure-in-ano) and results shall be compared with standard drug Jatyadi taila Matrabasti.

 
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