| CTRI Number |
CTRI/2025/07/089955 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to know the effect of application of tilanala kshara in haemorrhoids/piles |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of tilanala pratisaraneeya kshara in the management of abhyantara arshas (2nd and 3rd degree internal 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 Tanuja B M |
| Designation |
Pg Scholar |
| Affiliation |
Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal |
| Address |
Room no 16 department of pg studies in shalya tantra Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal karnataka india
Koppal
KARNATAKA
583231
India |
| Phone |
9686431916 |
| Fax |
|
| Email |
tanujabmtanu2815@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Hiremath |
| Designation |
Associate professor |
| Affiliation |
Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal |
| Address |
Room no 16 department of pg studies in shalya tantra Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal karnataka india
Koppal
KARNATAKA
583231
India |
| Phone |
7760346752 |
| Fax |
|
| Email |
sanjalihiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Hiremath |
| Designation |
Associate professor |
| Affiliation |
Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal |
| Address |
Room no 16 department of pg studies in shalya tantra Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal karnataka india
Koppal
KARNATAKA
583231
India |
| Phone |
7760346752 |
| Fax |
|
| Email |
sanjalihiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| shree jagadguru gavisiddeshwara ayurvedic medical college department of shalya tantra opd no 16 |
|
|
Primary Sponsor
|
| Name |
Dr Tanuja B M |
| Address |
Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal department of shalya tantra opd no 16 |
| 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 Tanuja B M |
Shree Jagadguru gavisiddheshwara ayurvedic medical College |
Room no 16 department of pg studies in shalya tantra Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal karnataka india
Koppal
KARNATAKA |
9686431916
tanujabmtanu2815@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru gavisiddheshwara ayurvedic medical College Koppal |
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 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Dr. Takral, Nibandha Sangraha Commentary of Shri Dalhanacharya and shri gayadas acharya nyachandrika vyakya Hindi translation, Sushrut Samhita, Vol-1, Sutrasthana, Varanasi, Chaukambha Sanskrit Samsthana, 1st edition-2014, reprint-2019, Chapter no. 11, Shloka no. 11, Procedure details: application of apamarga pratisaraneeya kshara under local anaesthesia of 2nd & 3rd degree internal haemorrhoids)
| | 2 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Prof. Priyavrata Sharma, editor and translater, Kaiyadeva Nighantu, Pathyaapathya Vibodhakah, Mishraka varga, Chaukambha Orienttaion, Varanasi, 1st edition-1979, Shloka no. 16, Pg.no. 564, pp 696. , Procedure details: application of tilanala pratisaraneeya kshara under local anaesthesia of 2nd & 3rd degree internal haemorrhoids )
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All subjects were diagnosed and assessed thoroughly on the basis of
Ayurvedic and modern signs and symptoms of internal haemorrhoids.
2nd and 3rd degree internal haemorrhoids.
Maximum 3 pile masses.
Age between 30 to 65 years |
|
| ExclusionCriteria |
| Details |
1st and 4th degree haemorrhoids
Bleeding haemorrhoids
Thrombosed pile mass
Subjects associated with any other chronic systemic disorder
Pregnant and lactating women
Chronic alcoholic and chronic liver diseases
Associated with any other Ano-rectal diseases
Carcinoma of Ano-rectal diseases
HIV, HCV and HBsAg positive patient
Uncontrolled DM Uncontrolled Hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in number and size of pile mass after application of tilanala pratisaraneeya kshara |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| standardisation of preparation of tilanala pratisaraneeya kshara |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0"
Months="10"
Days="10" |
|
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 can be rationally correlated to haemorrhoids in Contemporary science. The term
Arshas refers to illness which tortures the person like an enemy. Acharya Vagbhata
describes Arshas as Mamsankura’s which is protruding out and obstructing the Guda
marga1.
As the age advances, the incidence rate increases in both male and female and atleast 50%
are affected over the age of 50 years2. The prevalence rate of Haemorrhoids is 4.4% in the
world, in about 10 million people3. The modern treatment modalities in internal
haemorrhoids are Sclerotherapy, Rubber band ligation and Cryosurgery. Each procedure
carries it’s own complications4.
The Arshas which are Mrudu, Prasrutha, Avagadha and Uchrita should be treated by
Pratisaraneeya Kshara5. Acharya Sushruta mentioned Kshara mahatva as Chedya,
Bhedya, Lekhya, Tridoshagna6 and Kshara karma has a minimal invasive technique.
Therefore, use of Kshara in the management of Arshas is the need of the hour.
The drug Tilanala has been mentioned as one among the Kshara Panchaka in Kaiyadeva
Nighantu7. Tilanala is annual plant which is available in all seasons8, where as Apamarga
is seasonally available. Tilanala is easily available and cost effective. Tilanala is
Madhura, Kasaya, Tikta, Katu rasa pradhana, Ushna virya, Madhura vipaka and it
possesses the qualities of Vatahara, Vranahara, Sulaprashamana, Tridoshashamaka,
hence it can be taken in Abhyantara Arshas (2nd & 3rd Degree Internal Haemorrhoids).
Here an attempt is made to evaluate the efficacy of Tilanala Pratisaraneeya Kshara over
Apamarga Pratisaraneeya Kshara in the management of Abhyantara Arshas (2nd & 3rd
Degree Internal Haemorrhoids). |