| CTRI Number |
CTRI/2025/09/094451 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of application of alkali preparation from Apamarga and Palasha Kshar in Piles (2nd and 3rd degree) |
|
Scientific Title of Study
|
Comparative evaluation of Apamarga Kshar and Palasha Kshar Lepa in Raktarsha (IInd and IIIrd degree Haemorrhoids) |
| 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 Vishal Verma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No.7, Deptt. of Shalya Tantra, Rishikul Ayurved Hospital, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Haridwar Uttarakhand 249401 India
Haridwar
Uttarakhand
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
09719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Verma |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No.7, Deptt. of Shalya Tantra, Rishikul Ayurved Hospital, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Haridwar Uttarakhand 249401 India
Haridwar
Uttarakhand
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
09719314634 |
| Fax |
|
| Email |
vishalverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshit Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No.7, Deptt. of Shalya Tantra, Rishikul Ayurved Hospital, Rishikul Campus, Uttarakhand Ayurved University, Haridwar
Haridwar Uttarakhand 249401 India
Haridwar
Uttarakhand
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9410909381 |
| Fax |
|
| Email |
akshitchauhan9381@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.7, Rishikul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand, India pin code- 249401 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Harrawala, Dehradun, Uttarakhand, India pin code- 248001 |
| Type of Sponsor |
Government 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 |
| Akshit Chauhan |
Rishikul Campus, UAU, Haridwar |
OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurvedic hospital, Rishikul campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249401
INDIA
Hardwar
UTTARANCHAL |
9410909381
akshitchauhan9381@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional ethics committee,Uttarakhand Ayurved University, Rishikul campus, Haridwar |
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, (2) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushruta samhita chikitsa sthan 6/4, Procedure details: Method of Kshar Administration: The procedure of selected patients will be done in lithotomy position. Firstly anal canal and perianal area will be cleaned with antiseptic lotion. Proctoscopic examination will be done for confirmation of number and position of Arsha. These Arsha wil be made to protude in the slit proctoscope. After that Kshar will be applied with spatula on Arsha and then we will wait for 100 matrakal (2 minutes). Then the applied Kshar will be washed with nimbu swara. After the process, Arsha will become reddish brown ( Pakwajambuphal Sadrishya) in colour. It shows Samyak Lakshana of Kshar Lepa. Same procedure will be repeated on other mass of Arsha, if present.
3 sitting will be given at 7 days interval )
(1) Medicine Name: Apamarga, Reference: Sushruta samhita sutra sthan 11/12, Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 3(ml), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: sushruta samhita chikitsa sthan 6/4, Procedure details: Method of Kshar Administration: The procedure of selected patients will be done in lithotomy position. Firstly anal canal and perianal area will be cleaned with antiseptic lotion. Proctoscopic examination will be done for confirmation of number and position of Arsha. These Arsha wil be made to protude in the slit proctoscope. After that Kshar will be applied with spatula on Arsha and then we will wait for 100 matrakal (2 minutes). Then the applied Kshar will be washed with nimbu swara. After the process, Arsha will become reddish brown ( Pakwajambuphal Sadrishya) in colour. It shows Samyak Lakshana of Kshar Lepa. Same procedure will be repeated on other mass of Arsha, if present.
3 sittings will be given at 7 day interval)
(1) Medicine Name: Palasha, Reference: sushruta samhita sutra sthan 11/12, Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 3(ml), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Patients of age group between 16-70 years.
• Patients who are suffering from second and third degree of haemorrhoids will be considered for this study. |
|
| ExclusionCriteria |
| Details |
• I and IV degrees of piles.
• Arsha associated with carcinoma rectum, thrombosed & strangulated
piles, rectalprolapse, fistula in ano and fissure in ano.
• Hepatitis-B, HIV and HCV positive cases.
• Patients having uncontrolled systemic disease such as hypertension,
diabetesmellitus etc.,malignancy of any organ and pregnant women will
also be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be measured by parameters:
1.Bleeding per anus
2.Pain in anal region
3.Number of pile mass
4.Size of pile mass |
Outcome will be evaluated every 7th day for 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mucous discharge
2.constipation |
outcome will be evaluated every 7th day for 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
28/09/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [akshitchauhan9381@gmail.com].
- For how long will this data be available start date provided 10-09-2025 and end date provided 10-11-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Selected drug: Apamarga Kshar and Palasha Kshar
Form of medicine: Kshar will be applied in the form of Kshar Lepa as explained in the classical text
Composition of medicine: Apamarga Panchang, Palasha Patra
Preparation of medicine: Apamarga Kshar and Palasha Kshar will be prepared according to the classical views.
Dose of medicine: Kshar paste will be applied on each pile mass according to its size with protection of normal mucosa
Route of administration: Local application procedure: Method of Kshar Administration: The procedure of selected patients will be done in lithotomy position. Firstly anal canal and perianal area will be cleaned with antiseptic lotion. Proctoscopic examination will be done for confirmation of number and position of Arsha. These Arsha wil be made to protude in the slit proctoscope. After that Kshar will be applied with spatula on Arsha and then we will wait for 100 matrakal (2 minutes). Then the applied Kshar will be washed with nimbu swara. After the process, Arsha will become reddish brown ( Pakwajambuphal Sadrishya) in colour. It shows Samyak Lakshana of Kshar Lepa. Same procedure will be repeated on other mass of Arsha, if present. |