| CTRI Number |
CTRI/2026/02/104101 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Effect of Shatapushpa Oil Pichu and Jatyadi Oil Pichu in Patients Suffering from Parikartika (Anal Fissure). |
|
Scientific Title of Study
|
A randomised comparative clinical trial to evaluate the efficacy between
Shatapushpa Taila pichu and Jatyadi Taila pichu in the management of
Parikartika. |
| 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 Komal Ashok Dhage |
| Designation |
PG scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi Pune
MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8669052379 |
| Fax |
|
| Email |
dhagekomal70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Thirdfloor,Shalyatantra department Sector no.25 Pradhikaran, NigdiPune MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Thirdfloor,Shalyatantra department Sector no.25 Pradhikaran, NigdiPune MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantradepartment Sector no.25,Pradhikaran, Nigdi Pune MAHARASHTRA 411044India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Thirdfloor,Shalyatantra department Sector no.25,Pradhikaran, NigdiPune MAHARASHTRA 411044 India |
| 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 Komal Ashok Dhage |
Ayurved Rugnalaya and SnowbellMulti-speciality Hospital,Nigdi Pune |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi Pune
MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi Pune
MAHARASHTRA 411044 India
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA |
08669052379
dhagekomal70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa Tail, Reference: Bhavprakash purvakhanda, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -no any | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Taila, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -No any |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Include all patients of Parikartika irrespective of cause.
Parikartika (fissure in ano) and one or more of the following.
symptoms will be included.
Gudpradeshi daha (Burning Sensation at anal region),
Guda kandu (Itching),
Guda sankocha (anal spasm),
Gudgatraktastrav (P/R Bleeding),
presence or absence of sentinel tag,
Patients having age 19 to 60 years irrespective of gender,
religion, occupation, economical and marital status will be
selected.
|
|
| ExclusionCriteria |
| Details |
Patients with severe bleeding piles, fistula. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the clinical efficacy of Shatapushpa Taila Pichu and Jatyadi Taila
Pichu in the management of Parikartika upto 21 days, based on parameters such
as pain reduction, wound healing, and relief from bleeding.
|
15 days treatment with follow ups on 5th, 10th, & then on 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe any local adverse effects associated with the use of Shatapushpa Taila
Pichu & Jatyadi Taila Pichu in the management of Parikartika upto 21 days. |
15 days treatment with follow ups on 5th, 10th, & then on 15th day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Today most of the diseases are related to our day to day schedule one of them are Ano-rectal diseases. Nowadays due to sedentary life and changing food habits digestive related problems are increasing day by day. Ultimately improper bowel habit and constipation leads to the passage of hard stool. Finally it causes erosion and ulceration over anal mucosa which is named as Parikartika (fissure in ano). Parikartika can be co-related with Fissure in ano based on their symptoms. The disease Fissure in Ano falls into two categories viz. Acute Fissure in ano and Chronic fissure in ano depending upon the duration of symptoms. The cutting pain and burning pain are the cardinal symptoms of Parikartika. Hence, we can understand that there is an involvement of Vata and Pitta Dosha. In Ayurveda a successful management of this condition has been described. The treatment of Parikartika depends on pacifying Vata and Pitta Dosha and the treatment told in classics for this condition are Pichabasthi, Anuvasanabasthi, Pichu, Parisheka and local administration of Snehadravya. Acharya Charak has also mentioned parikartika as complication of vamana and virechana. If vamana and virechana with tikshna, ushna and pitta prakopaka medicine is given to the patient having mridu koshtha and mandaagni then pitta and vata prakopa leads to parikartika, atiyoga of virechana. If Basti of tikshna, ushna and lavan dravya is given to mridu koshtha patient then leads to parikartika. The rough introduction of Basti netra also causes parikartika. Shatpushpa Taila mentioned in Bhavprakash describes its use in wound healing. Fissure in ano has a major symptom which is pain, which requires pain relief and soothing effect and it can be achieved with the help of local application of Taila . There are many ointments and jellies available in local market. But they have only lubricating and temporary pain relief to some extent and has no role in healing of fissures. There is always a need for the cost effective and patient friendly method of management of parikartika. In this study there is an attempt to see the efficacy of Shatpushpa Taila as pain relief and its healing effect in acute fissure in ano. So, there is an attempt to see its efficacy in the management of Parikartika. |