| CTRI Number |
CTRI/2025/08/093608 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Anorectal Postoperative pain management by application of Dashmoola ghrita pichu |
|
Scientific Title of Study
|
Randomised controlled clinical trial of Dashmoola Ghrita Pichu in Post Operative Pain Management (Ano rectal post operative cases )within 5 days after surgery. |
| 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 vaishnavi Chandrashekhar Ghate |
| Designation |
Post Graduate scholar |
| Affiliation |
PMTs Ayurved College |
| Address |
Trimurti Nagar, zade lay out , near Bhavani Mata Temple , Wardha
PMTs Ayurved College ,Datta Nagar , Shevgaon, Ahamadnagar
Ahmadnagar
MAHARASHTRA
442001
India |
| Phone |
7972983092 |
| Fax |
|
| Email |
vaishnavighate17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumedh Wasnik |
| Designation |
HOD & Professor of shalya tantra department |
| Affiliation |
PMTs Ayurved College Shevgaon Ahmadnagar |
| Address |
PMTs Ayurved College Shevgaon Ahmadnagar
PMTs Ayurved College, Datta Nagar ,Shevgaon,Ahamadnagar
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
98227 68267 |
| Fax |
|
| Email |
drsumedh.wasnik14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumedh Wasnik |
| Designation |
HOD & Professor of shalya tantra department |
| Affiliation |
PMTs Ayurved College Shevgaon Ahmadnagar |
| Address |
PMTs Ayurved College, Datta Nagar ,Shevgaon,Ahamadnagar
PMTs Ayurved College, Datta Nagar ,Shevgaon,Ahamadnagar
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
98227 68267 |
| Fax |
|
| Email |
drsumedh.wasnik14@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD OF shslya tantra , Shri Eknath Ayurved Rugnalaya, PMTs Ayurved College Shevgaon Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
Dr vaishnavi Chandrashekhar ghate |
| Address |
PMTs Ayurved College Shevgaon Ahmadnagar, 414502 |
| 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 vaishnavi ghate |
IPD Of Shalya tantra, PMTs Ayurved College Shevgaon |
Shri Eknath Ayurved Rugnalaya PMTs Ayurved College Shevgaon Ahmadnagar , 414502
Ahmadnagar
MAHARASHTRA |
7972983092
vaishnavighate17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmoola ghrita , Reference: Sharangdhara samhita , Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Application of Dashmoola ghrita pichu | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu ghrita, Reference: Sushrutasamhitha , Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Application of yashtimadhu ghrita pichu |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Post-operative patients between the age group of 20-80 years who underwent Fissurectomy/Haemorrhoidectomy/Fistulotomy, Lord’s dilatation.
2.Gender-Both male and female
|
|
| ExclusionCriteria |
| Details |
Patients who were: pregnant or lactating.
2.Patients not willing for local application of DashmoolaGhritapichu .
3.operated for fissure-in-ano/haemorrhoids/fistula-in-ano associated with IBS or diagnosed with Crohn’s disease, in immune compromised state, suffering from systemic diseases like diabetes mellitus, tuberculosis.
4.positive for human immunodeficiency virus (HIV), venereal disease and hepatitis-B, CA rectum.
5. Patient unfit for surgery will be excluded for this study .
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of dashmoola siddha ghrita pichu in post operative pain management . |
adviced for 5 to 7 days after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirment of analgesic after Wean off Anasthesia.
Daily Requirement of Analgesic after use of Pichu .
Time of Pain reduction after insertion of Pichu
Total Number of Pichu used within 5 days on one patient |
adviced for 5 to 7 days after surgery. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
05/09/2025 |
| 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="18" |
|
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
|
Randomized selection of patient which is according to inclusive criteria patient is selected and according to that for one group Dashmoola ghrita pichu is given and for other group yashtimadhu ghrita is given and after that conclusion is taken out and data will be prepare according that |