| CTRI Number |
CTRI/2025/09/094336 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess and compare the effectiveness of injection therapy and apamarga kshara karma (an Ayurvedic procedure)in patients with piles(hemorrhoids). |
|
Scientific Title of Study
|
A clinical study to eveluvate the efficacy of injection therapy and apamarga kshara in 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 UDAYAN BHADRA |
| Designation |
POST GRADUATE |
| Affiliation |
Institute |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA,
D.K. DISTRICT -574327 KARNATAKA
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9488038376 |
| Fax |
|
| Email |
udayanbhadra4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr SAHANA S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Institute |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA,
D.K. DISTRICT -574327 KARNATAKA
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8722613431 |
| Fax |
|
| Email |
drjois@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr UDAYAN BHADRA |
| Designation |
POST GRADUATE |
| Affiliation |
Institute |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA,
D.K. DISTRICT -574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9488038376 |
| Fax |
|
| Email |
udayanbhadra4@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA,
D.K. DISTRICT -574327, KARNATAKA, INDIA.
|
|
|
Primary Sponsor
|
| Name |
Dr UDAYAN BHADRA |
| Address |
KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA,
D.K. DISTRICT -574327 KARNATAKA
|
| 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 UDAYAN BHADRA |
KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, SULLIA. |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA, KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA,
D.K. DISTRICT -574327 KARNATAKA, INDIA.
Dakshina Kannada KARNATAKA |
9488038376
udayanbhadra4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL, AMBATE ADKA, SULLIA, D.K. DISTRICT -574327 KARNATAKA |
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 | Comparator Arm | Procedure | - | kShAra-karma, क्षार-कर्म | (Procedure Reference: Sushruta samhita, Procedure details: Application of apamarga kshara & observation for 14 days)
| | 2 | Intervention Arm | Procedure | - | Injection therapy | (Procedure Reference: NICE Guidelines (UK, 2010; updated 2023), Procedure details: Injecting almond oil with 5% phenol to the pile mass & observation till 14 days )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18yrs and below 70 yrs of age.
2. Presence of signs and symptoms of Arshas.
3. No discrimination of gender, chronicity or socio economic status.
4. Patient ready to participate and sign the informed written consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 yrs and above 70 yrs of age.
2. Patients with other serious systemic disorders
3. Contra-indications of Kshara Karma.
4. Contra-indications of Injection Therapy.
5. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the reduction in size of arshas, pain and difficulty while defecation, |
2 WEEKS(14 DAYS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving the quality of life in patients diagnoised with arshas |
AFTER 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 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 Yet Recruiting |
| 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
|
Arshas which is compared to haemorrhoids in
the contemporary science is the commonest
ano-rectal condition seen in the practice of proctology. The dilated
veins within the anal canal in the sub-epithelial region formed by radicles of
superior, middle and inferior rectal veins are called as Haemorrhoids.
Incidence of this disease can be traced since Vedic period. Its incidence
increases with advancing age, at least 50% of people over the age of 50 years
have some degree of haemorrhoidal symptoms. Now a day’s most of the persons
suffer from any one of the complaints of piles during their life time. The ancient medical authorities like Acharya
Charaka and Acharya Sushruta both have described four types of measures for the
treatment of Arsha. These are Bheshaja, Kshara,
Agni and Shastra. Acharya Sushruta speaks much about Kshara, Agni,
Shastrakarma. While going through the chapter of treatment of the disease Arshas,
it becomes quite evident that Kshara Karma has been indicated for all the
varieties of Arshas, that even the pedunculated and Arsha of a very big size
can also be successfully treated with the help of Kshara Karma.
Hence the repeated advocacy of Kshara Karma by almost all the ancient Acharya
in the disease Arshas has given an inspiration to work on the disease Arsha
with the help of Pratisaraneeya Kshara, because of its simple technique and it
has important properties like Chedana, Lekhana, Ropana.
Pratisaraneeya Kshara
described as an upakrama, substitute for surgical instruments, can be used
safely in patients who are afraid of surgery. The detailed description of many
Kshara preparations are available in Susruta Samhitha.
According to modern surgery haemorrhoids,
which are not treated properly or neglected, may lead to complication such as
strangulation, thrombosis, portal pyaemia, suppuration, haemorrhage etc. The
management of haemorrhoids in modern medical science is changing from
conventional surgical procedure i.e., Haemorrhoidectomy to other procedures
like Injection Therapy, Rubber band ligation, Cryosurgery, Laser therapy etc. Injection therapy is a form of sclerotherapy, where 5% Phenol with Almond oil is injected
submucosally causing fibrosis in submucosal region and thereby fixation of the
anal cushions which do not prolapsed. Hence an
effort is made to compare and evaluate the efficacy of Injection therapy and
Apamarga Pratisaraneeya Kshara in Arshas. |