| CTRI Number |
CTRI/2024/09/073811 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management Of Arsha (Piles) By Changeri Ghrita Ointment And Kasisadi Taila Ointment. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Changeri Ghrita Ointment And Kasisadi Taila Ointment In The Management Of Arsha (First And Second Degree Haemorrhoids). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudipkumar Prakashbhai Modi |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9662265997 |
| Fax |
|
| Email |
sudipmodi249@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay L Trivedi |
| Designation |
PROFESSOR |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
8128012211 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay L Trivedi |
| Designation |
PROFESSOR |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
8128012211 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr. Sudipkumar Prakashbhai Modi |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
| 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 Sudipkumar Prakashbhai Modi |
S. G. Patel Ayurveda Hospital and Maternity Home |
Department of Shalya Tantra, OPD No. 25, New Vallabh vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT |
9662265997
sudipmodi249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J.Patel Institute Of Ayurvedic Studies And Research & S.G.Patel Ayurveda Hospital & Maternity Home Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Changeri Ghrita Ointment, Reference: Sharangadhara Samhita Madhyama Khanda 9, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kasisadi Taila Ointment, Reference: Sushruta Samhita Chikitsasthan 6, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants age group between 18 years to 60 years.
2) Participants presenting with Signs and Symptoms of Arsha (first and second degree haemorrhoids).
3) Participants will be selected irrespective of their gender, caste, religion, and profession. |
|
| ExclusionCriteria |
| Details |
1) Participants of age less than 18 years and more than 60 years of age.
2) Participants suffering from Any other anorectal conditions associated with haemorrhoids Except first and second degree haemorrhoids.
3) Participants suffering from Any malignancy.
4) Known case of comorbid conditions i.e. HTN, DM, Liver disease, Portal HTN, HIV and HBsAg Participants.
5) Pregnant lady and lactating lady.
6) Fissure-in-Ano, fistula-in-ano, Haemorrhoids with ulcerative colitis or Crohn s disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changeri Ghrita Ointment and Kasisadi Taila Ointment will have effect in symptomatic relief, i.e. Pain in ano, Itching in ano, Burning in ano, Per rectal bleeding, Mucous discharge in ano in Arsha (First and Second Degree of Haemorrhoids). |
7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changeri Ghrita Ointment And Kasisadi Taila Ointment will do shrinkage of pile mass. |
14 days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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)
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
|
In a Randomised Comparative Clinical Study, 30 participants will be selected and equally divided into two groups. Trial Drug Group A Changeri Ghrita Ointment will be given for local application in ano and In Comparator Drug Group B Kasisadi Taila Ointment will be given for local application in ano 5 gm twice a day for 14 days. Along with in both groups internal medicine Erandbristha Haritaki Churna 5 gm H.S with warm milk for 14 days. Warm water sitz bath will be given in both groups Twice a day for 14 days. Follow-up will be taken every 7th day of treatment for up to one month. Assessment will be done with a case record form with criteria like Pain in ano, Itching in ano, Burning in ano, Mucous discharge in ano, Per rectal bleeding, and Degree of pile mass. Collected data will be analyzed statistically using suitable methods, and a conclusion will be drawn. |