| CTRI Number |
CTRI/2025/07/091622 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of herbal paste made from triphala and aloe vera in severe prolapsed piles |
|
Scientific Title of Study
|
Effect of topical application of triphala kumari kalka in third and fourth degree haemorrhoids |
| Trial Acronym |
TKLH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mary Grace P S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department of shalyatantra
Government Ayurveda College
Kannur
Kannur
KERALA
670503
India |
| Phone |
9946595279 |
| Fax |
|
| Email |
gracemarygrace91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Gangadharan |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department Of Shalyatantra
Government Ayurveda College Kannur
Kannur
KERALA
670503
India |
| Phone |
9496777170 |
| Fax |
|
| Email |
drkganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mary Grace P S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Department Of Shalyatantra
Government Ayurveda College Kannur
Kannur
KERALA
670503
India |
| Phone |
9946595279 |
| Fax |
|
| Email |
gracemarygrace91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Kannur,Kerala, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Mary Grace P S |
| Address |
Paruthiyil House
Kattoor P O
Alappuzha
PIN 688522
KERALA
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 Mary Grace P S |
Government Ayurveda College Kannur |
Department Of Shalyatantra
OP number 10
PIN 670503
Kannur
KERALA |
9946595279
gracemarygrace91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDA HOSPITAL PARIYARAM KANNUR, PARIYARAM MEDICAL COLLEGE KANNUR |
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: Triphala Kumari, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: This study evaluates the effect of a classical Ayurvedic formulation — Triphala Kumari Kalka — in managing advanced stages of Arsha (third and fourth degree hemorrhoids) through topical application. Both ingredients are well-documented in classical texts Charaka Samhita and Bhaishajya Ratnavali in the context of Arsha Chikitsa for their Shothahara or anti inflammatory and Ropana or wound healing properties.
The study follows a non-randomized, single arm, open label, pre post design in a well defined group of patients. The intervention is classical, safe and does not require surgical intervention, which makes it a promising conservative alternative.
Proper ethical clearance has been obtained and patient consent will be taken in written form.
Equal quantity of Haritaki, Vibheetaki and Amalaki are made in to fine powder. Mix it with equal quantity of freshly collected pulp of Aloe Vera, till it attain a paste form.
Patient in lithotomy position. Clean the haemorrhoid mass and perianal region with Triphala kashaya.Prepared Lepa apply on the surface of the haemorrhoid mass in 6.5mm or ¼ angula thickness. Cover the same with sterile cotton pad.Lepa will be kept in Situ till next defecation or for 1 hour. Internally 1 tsp Triphala choornam with warm water provided as BID.
Outcome measures include pain, bleeding, prolapse size Burning sensation and Pruritus ani.Treatment continue the treatment twice daily for 21 days. Assess the parameters on 0th day,
5 th day, 10th day, 15th day and 22nd day. Follow up on 45th day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of 3rd and 4th degree Haemorrhoids.
2. Bleeding and non-bleeding Haemorrhoids.
3. Participants who give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Haemorrhoids associated with known case of malignancy.
2. Prolapsed rectum.
3. Diagnosed case of HIV/AIDS, HBsAg and other STD
4. Haemorrhoids associated with fistula or fissure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Bleeding per rectum
Burning Sensation
Pruritus ani
Size of Prolapsed Pile mass |
on 5th 10th 15th 22nd days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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)
|
10/08/2025 |
| 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="1"
Months="0"
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
|
This study evaluates the effect of a classical Ayurvedic formulation Triphala Kumari Kalka in managing advanced stages of Arsha like third and fourth degree hemorrhoids through topical application. Both ingredients are well documented in classical texts Charaka Samhita and Bhaishajya Ratnavali in the context of Arsha Chikitsa for their Shothahara or anti inflammatory and Ropana or wound healing properties. The study follows a non randomized, single arm, open label, pre post design in a well defined group of patients. The intervention is classical, safe and does not require surgical intervention, which makes it a promising conservative alternative. Proper ethical clearance has been obtained and patient consent will be taken in written form. Equal quantity of Haritaki, Vibheetaki and Amalaki are made in to fine powder. Mix it with equal quantity of freshly collected pulp of Aloe Vera, till it attain a paste form. Patient in lithotomy position. Clean the haemorrhoid mass and perianal region with Triphala kashaya.Prepared Lepa apply on the surface of the haemorrhoid mass in 6.5mm or ¼ angula thickness. Cover the same with sterile cotton pad. Lepa will be kept in Situ till next defecation or for 1 hour. Internally 1 tsp Triphala choornam with warm water provided as BID. Outcome measures include pain, bleeding per rectum, prolapse size, burning sensation and pruritus ani. Continue the treatment twice daily for 21 days. Assess the parameters on 0th day, 5 th day, 10th day, 15th day and 22nd day. Follow up on 45th day. During visit patient will be assessed on clinical features listed in the assessment criteria and also will be clinically examined and the same will be documented. |