| CTRI Number |
CTRI/2025/02/081183 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand the effect of Nimbadibeeja varti (anal suppository) in non bleeding piles |
|
Scientific Title of Study
|
Clinical study to evaluate the effect of Nimbadibeeja varti in Haemorrhoids with special reference to Shushka Arshas |
| 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 Suresh Kumar C |
| Designation |
Professor and HOD |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre Kattakada, Thiruvananthapuram |
| Address |
Department of Shalyatantra
Pankajakasthuri Ayurveda Medical College and PG Centre
Kattakada po
Thiruvananthapuram
pin 695572
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447160480 |
| Fax |
|
| Email |
Drsureshtriveni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajalekshmi L |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre Kattakada, Thiruvananthapuram |
| Address |
PGscholar
Department of Shalyatantra Pankajakasthuri Ayurveda Medical College and PG Centre
Kattakada po
Thiruvananthapuram
pin 695572
Thiruvananthapuram
KERALA
695572
India |
| Phone |
8891737074 |
| Fax |
|
| Email |
raju.kukku.l@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajalekshmi L |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical college and PG centre Kattakada, Thiruvananthapuram |
| Address |
PGscholar
Department of Shalyatantra Pankajakasthuri Ayurveda Medical College and PG Centre
Kattakada po
Thiruvananthapuram
pin 695572
KERALA
695572
India |
| Phone |
8891737074 |
| Fax |
|
| Email |
raju.kukku.l@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College and PG Centre
Kattakada po
Thiruvananthapuram
pin 695572 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Student funded MD project] |
|
|
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 Rajalekshmi L |
Pankajakasthuri Ayurveda Medical college and PG Centre Hospital |
Room no H 04, Department of Shalyatantra
Kattakada po
Thiruvananthapuram
pin 695572
Thiruvananthapuram
KERALA |
8891737074
raju.kukku.l@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) Pankajakasthuri Ayurveda Medical College and PG Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbadibeeja Varti, Reference: Gadanigraha, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Ghee smeared for lubrication prior to administration |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed cases of first, second and third degree Haemorrhoids.
2.Non bleeding Haemorrhoids
3.Subjects willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1. Haemorrhoids associated with malignancy, ulcerative colitis, and rectal prolapse
2.Haemorrhoids that are bleeding, fourth degree, strangulated and thrombosed
3.Subjects diagnosed with systemic illness
4.Pregnanat ladies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of medicine in the symptoms like
1. Degree of protrusion of pile mass
2. pruritis ani
3. constipation
4.mucous discharge |
Subjective parameters will be assessed at baseline ,4th day, 8th day and 15th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the quality of life after the treatment |
Subjective parameters will be assessed on 15th day as follow up |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
12/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Haemorrhoids are dilated veins in the anal canal in the sub epithelial region formed by the radicles of superior, middle and inferior rectal veins. It is one of the commonest ailment that afflict mankind. The incidence of this disease is found to be affecting 50% of population at a time and mostly after 50 years, especially men. Owing to unhealthy dietary pattern, low fibre diet , inhibition of natural urges and mental stress coupled with sedentary lifestyle increased the vulnerability to this disease. The common symptoms include mass per rectum, bleeding, itching etc. Acharyas described different types of haemorrhoids (arsas) based on dosa predominance. One among such classification is Shushka ( non bleeding) and Ardra( bleeding) haemorrhoids. There are different types of internal and external treatment described in classical texts, one among them is varti prayoga. It can be easily administered by the patient himself. The study will be conducted in 32 subjects , irrespective of gender, within the age group of 20 to 70 years, satisfying inclusion and exclusion criteria, selected from the OPD and IPD of Shalyatantra, Pankajakasthuri Ayurveda Medical college and PG centre hospital, Kattakada, Thiruvanandapuram. Symptoms assessed based on assessment criteria. The varti is prepared from the seeds of nimba, indravaruni and devathali added with jaggery. Varti weighing 3 grams 1 inch length, yavakrithi is prepared. This will be administered per rectally, once daily for 7 days after smearing with ghee. The assessment done on before treatment, 8th and 15th day. The data will be analysed using appropriate statistical tests. |