| CTRI Number |
CTRI/2025/04/084734 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Namaskari ointment and Shatadhauta ghrita in parikartika |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Namaskari ointment with Shatadhaut ghrita 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 Subodh Ravindra Bijwe |
| Designation |
MS Scholar Shalyatantra (Ayurveda) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Shalyatantra Department OPD No.3 ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9096508455 |
| Fax |
|
| Email |
subodhrbijwe7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh D. Narkhede |
| Designation |
Assistant professor Shalyatantra department, MS Shalyatantra |
| Affiliation |
|
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Shalyatantra Department OPD No.3 ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9850200998 |
| Fax |
|
| Email |
dryogeshnarkhede10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subodh Ravindra Bijwe |
| Designation |
MS Scholar Shalyatantra (Ayurveda) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Shalyatantra Department OPD No.3 ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9096508455 |
| Fax |
|
| Email |
subodhrbijwe7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra,Sane Guruji Arogya Kendra,MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi, Hadapsar, Pune 411028,India |
|
|
Primary Sponsor
|
| Name |
Dr Subodh Ravindra Bijwe |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Shalyatantra Department OPD No.3 ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune,411028 ,Maharashtra,India |
| Type of Sponsor |
Other [Self] |
|
|
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 Subodh Ravindra Bijwe |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
Department Of Shalyatantra OPD NO 3 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA |
9096508455
Subodhrbijwe7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MAMs Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya Kendra Hadapsar Pune |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatadhauta ghrita , Reference: BhaishajyaKalpana vidnyana by Dr A. Agnihotri 1st edition pg no 268, Route: Topical, Dosage Form: Ghrita, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Namaskari ointment , Reference: Rajanighantu of pandit narahari,Dravyagunprakashika,pg no 125-126, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having clinical sign and symptoms of Parikartika (Fissure in Ano). 2) Patient Diagnosed as having Parikartika (Fissure in Ano). 3) Irresepective of gender between the age group of 19-60 year 4) Per rectal bleeding with cutting pain at anal region 5) Burning at Anal Region |
|
| ExclusionCriteria |
| Details |
1)K/C/O ulcerative colitis , Crohn’s disease, Syphilis And Tuberculosis 2) Patient suffering from malignancy of any organ or Ano rectum will be excluded 3) K/C/O HIV and HbsAg, VDRL will be excluded 4) uncontrolled cases of DM and Hypertension will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Namaskari ointment and Shatadhauta ghrita in Parikartika |
Oth day, 3rd day, 5th day ,7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of Namaskari ointment in Parikartika |
Oth day, 3rd day,5th day,7th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/04/2025 |
| 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="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(Fissure-in-ano) is one of the commonest ano rectal disorder, even though it is not life threatening but very painful to sufferers in the present era. The modern surgeries cause many complications like haematoma, perianal abscess, persistent mucous discharge anal incontinence and these surgeries are expensive and recurrence rate is higher. That’s why to manage it by conservative and easy way Namaskari Ointment has been selected in the treatment of Parikartika (Fissure-in-ano). Namaskari (Lajjalu) has a sheeta virya which helps in the management of daha (burning sensation) at anal region . It has a kashaya tikta rasa, katu vipaka which helps in wound healing (Parikartika) . So the Namaskari ointment is selected for the study |