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CTRI Number  CTRI/2025/08/092974 [Registered on: 13/08/2025] 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   Comparing Panchavalkala Cream and Povidone Iodine Ointment for Faster Healing of Surgical Wounds in Adult Patients with Chronic Fissure in Ano after surgery 
Scientific Title of Study   A Comparative Clinical Study to Evaluate the Efficacy of Topical Application of Panchavalkala Cream versus Povidone Iodine Ointment in the Management of Post-Operative Wound of Parikartika (Chronic 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 Sambhaji S Garje 
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 Shalya Tantra Department Proctology Division Inchal Saundatti Taluk Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA
591102
India 
Phone  9869632064  
Fax    
Email  sambhajigarje@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Patil 
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 Shalya Tantra Department Proctology Division Inchal Saundatti Taluk Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA
591102
India 
Phone  8310861794  
Fax    
Email  sachinpatilrss@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sambhaji S Garje 
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 Shalya Tantra Department Proctology Division Inchal Saundatti Taluk Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA
591102
India 
Phone  9869632064  
Fax    
Email  sambhajigarje@gmail.com  
 
Source of Monetary or Material Support  
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital Room No 35 Shalya Tantra Department Proctology Division Inchal Saundatti Taluk Belagavi District Karnataka 591102 India 
 
Primary Sponsor  
Name  Dr Sambhaji S Garje 
Address  Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital Room No 35 Shalya Tantra Department Proctology Division Inchal Saundatti Taluk Belagavi District Karnataka 591102 India 
Type of Sponsor  Other [Self Dr Sambhaji S Garje] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Sambhaji S Garje  Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital, Inchal  Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital Room No 35 Shalya Tantra Department Proctology Division Inchal Saundatti Taluk Belagavi District Karnataka 591102 India
Belgaum
KARNATAKA 		 9869632064

sambhajigarje@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K601||Chronic anal fissure. Ayurveda Condition: PARIKARTIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sushruta, Sushruta Samhita, Sutra Sthana. Mishrakam adhyayam 37/22. In: Acharya VJ, editor. reprint ed. Varanasi: Chaukhambha Orientalia; 2009. p. 162, Procedure details: patients will undergo fissurectomy procedure followed by local application of panchavalkala cream for 21 days)
(1) Medicine Name: panchavalkala cream, Reference: Sushruta, Sushruta Samhita, Sutra Sthana. Mishrakam adhyayam 37/22. In: Acharya VJ, editor. reprint ed. Varanasi: Chaukhambha Orientalia; 2009. p. 162, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Duration: 21 Days
2Comparator Arm (Non Ayurveda)-Povidone Ointmentpatients will undergo fissurectomy procedure followed by local application of povidone iodine ointment for 21 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of both sexes irrespective of religion, occupation, socio-economic status, etc.
2. Patients who are clinically diagnosed as a case of parikartika and have undergone fissurectomy procedure recently.
3.Patients preferably aged between 18-60 years.
4.Patients willing to sign informed consent and ready to a bide to study protocol. 
 
ExclusionCriteria 
Details  1. Patients suffering from systemic diseases like Diabetes mellitus, Hypertention, Tuberculosis will be excluded from the study.
2. Patients found associated with HbsAg +ve and HIV +ve will be excluded from the study.
3. Patients of fissure-in-ano associated with other Ano-rectal conditions like Hemorrhoids, Fistula-in-ano, Ca Rectum and also suffering from ulcerative colitis, chron’s disease etc. will also be excluded from the study. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Bleeding during and Post defecation
Tag Removal
Healing Fissure Bed 		 21 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in pain
Normalizing Sphincter tone 		 21 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="21" 
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  

REVIEW OF LITERATURE

  1. Disease Review

a Ayurvedic Review
Parikartika is explained under the Vamana and Virechana Vyapada. Nidana, Samprapti, and Lakshana of Parikartika are explained in Sushruta Samhita Chikitsa Sthana Chapter 34 Verse 16.
The major texts of Ayurveda, Charaka Samhita and Sushruta Samhita, described Parikartika as complications Vyapat of Basti and Virechana. Nidana, Samprapti, Lakshana, and Chikitsa of Parikartika are mentioned in these texts. Acharya Kashyapa described Parikartika and its types in Garbhini Chikitsa.

b Modern Review
Definition, etiology, pathology, signs and symptoms, examination, and treatment of fissure-in-ano will be reviewed.

  1. Drug Review
    The detailed description of Panchavalkala cream and Povidone Iodine ointment in post-operative wound management of Parikartika chronic fissure-in-ano will be reviewed critically.

AIMS AND OBJECTIVES OF STUDY

  1. To review Parikartika and fissure-in-ano in detail

  2. To evaluate the efficacy of Panchavalkala cream in post-operative wound management of Parikartika

  3. To evaluate the efficacy of Povidone Iodine ointment in the same condition

  4. To compare and ascertain the efficacy of both treatments in the post-operative wound management of Parikartika

HYPOTHESIS

a Null Hypothesis H0
There is no statistically significant difference between the efficacy of Panchavalkala cream and Povidone Iodine ointment.

b Alternative Hypothesis H1
There is a statistically significant difference in efficacy.

MATERIAL AND METHODS

7.1 SOURCE OF DATA

A Literary Source
Texts of Ayurveda, modern references, and online sources

B Drug Source
From SSRAMC Pharmacy Inchal
i. Raw material from approved vendors
ii. Cream preparation at SSRAMC lab
iii. Povidone iodine from authorized pharmacy

C Sample Source
Patients diagnosed with chronic fissure-in-ano from OPD and IPD of Shalya Tantra, SSRAMC, Inchal

Grouping

  • Type of Study: Interventional

  • Design: Two-arm, open-labeled, active controlled, randomized prospective clinical study

  • Sampling: Purposive

  • Sample Size: 60 patients

  • Group A: Panchavalkala cream application for 21 days

  • Group B: Povidone Iodine ointment application for 21 days

  • Treatment Duration: 21 days

Plan of Study
Fissurectomy followed by local application. Diet advice, antibiotics, analgesics, and discharge by third day. Application of ointments for 21 days with sitz bath.

ASSESSMENT CRITERIA

Pain – Oozing – Ulcer – Discharge

ASSESSMENT CRITERIA:

GRADATION

PAIN

OOZING OF BLOOD

ULCER  IN

ANO

ANY

DISCHARGE

0

No pain

Nil/ spotless gauze

No ulcer

No discharge

1

Pain at the time defeacation and subside within 30 minutes

Few drops of blood in gauze 2’’X2’’

Presence of ulcer with indurated margins

Mild discharge and no requirements of pads

2

Pain at the time defecation and subside more than 30 minutes to 1 hour

Half gauze wetted with blood 2’’X2’’

Presence of ulcer with indurated margins

Changing of pads one a day

3

Continuous unbearable pain which persist for

More than 1 hour

Total gauze wetted with the blood 2’’X2’’

Presence of ulcer with indurated margins and slough

Changing of pads more than once a day

 FOLLOW-UP

Once per week for 4 weeks

 
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