| CTRI Number |
CTRI/2025/04/084320 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Tilvak Pratisarniya Kshara In Abhyantar Arsha (Internal Haemorrhoids) |
|
Scientific Title of Study
|
Randomised Controlled Trial On Tilvak Pratisarniya Kshara In The Management Of Abhyantar Arsha (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 |
Gawali Pranil Rajendra |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Plot no. 6/38, Raje Raghuji Nagar, Near Maske Jewellers, Near Sakkardara Square, Nagpur 440024
Department of Shalyatantra OPD no.3, Government Ayurved College and Hospital, Raje Raghuji Nagar, Near Sakkardara Square, Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8928918799 |
| Fax |
|
| Email |
pranilraje99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nita Kedar |
| Designation |
HOD and Professor |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Near Krishna Mandir D-1 Kulkarni Apartment, Navneet Society, Narendra Nagar, Vivekanand Nagar, Nagpur
Department of Shalyatantra OPD no.3, Government Ayurved College and Hospital, Raje Raghuji Nagar, Near Sakkardara Square, Nagpur 440024
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
Drnita6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nita Kedar |
| Designation |
HOD and Professor |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Near Krishna Mandir D-1 Kulkarni Apartment, Navneet Society, Narendra Nagar, Vivekanand Nagar, Nagpur
Department of Shalyatantra OPD no.3, Government Ayurved College and Hospital, Raje Raghuji Nagar, Near Sakkardara Square, Nagpur 440024
Nagpur
MAHARASHTRA
440015
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
Drnita6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital, Nagpur, Maharashtra, India, 440024 |
|
|
Primary Sponsor
|
| Name |
Gawali Pranil Rajendra |
| Address |
Department of Shalyatantra OPD no.3, Government Ayurved College and Hospital, Raje Raghuji Nagar, Near Maske Jewellers, Sakkardara Square, Nagpur 440024 |
| 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 Pranil Rajendra Gawali |
Government Ayurved College and Hospital, Nagpur, Maharashtra, India, 440024 |
Department of Shalyatantra OPD no.3, Government Ayurved College and Hospital, Raje Raghuji Nagar, Near Sakkardara Square, Nagpur 440024
Nagpur
MAHARASHTRA |
8928918799
pranilraje99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurved College, Nagpur |
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: Tilvak Kshara, Reference: Sushruta Samhita Lodhradi Gana, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 12 Days, anupAna/sahapAna: No, Additional Information: Application of kshara upto 100 counting according to Sushruta | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarga Kshara, Reference: Sushruta Samhita Sutrasthan 11, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 12 Days, anupAna/sahapAna: No, Additional Information: Application of Kshara upto 100 counting according to Sushruta Samhita |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in study.
Patients having age between (18) to (60) yrs will be selected for the study.
Patients having (I°) and (II°) Internal Haemorroids.
Patients will be selected irrespective of sex, religion, marital status, educational and economic status.
Patients having symptoms like Per rectal bleeding, Pain, Itching, Mucous discharge.
Patients having controlled DM (70-180 mg/dl) will be selected.
Patients having controlled HTN |
|
| ExclusionCriteria |
| Details |
Patients having (III°) and (IV°) Haemorrhoids.
Patients having uncontrolled DM (BSL greater than 180mg/dl).
Severe anaemic patients. (Hb lesser than 8 gm%).
Patients of Internal Haemorrhoids with acute fissure in ano.
Haemorrhoids with pelvirectal or ischiorectal abscess.
Patients requiring any medical emergencies.
Patients requiring immediate surgical action.
Non-co-operative patients.
Immuno-compromised patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of Tilvak Kshara Pratisarana in the management of Abhyantar Arsha (Internal Haemorrhoid) |
On the 0th,4th,8th,12th day of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate the efficacy of Apamarga Kshara Pratisarana in the management of Abhyantar Arsha (Internal Haemorrhoid)
To compare the efficacy of Tilvak Kshara Pratisarana and Apamarga Kshara Pratisarana in the management of Abhyantar Arsha (Internal Haemorrhoid)
To review the literature regarding Arsha through the Ayurvedic and Modern classical texts with recent research articles. |
On the 0th,4th,8th,12th day of trial |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2025 |
| 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 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
|
After clearance of institutional ethics of Government Ayurveda College Nagpur screening of population will be done from patient in OPD and IPD of our institute. In clinical study of 30 patients in each group of Abhyantar Arsha will be include. If patients fulfill the criteria of inclusion, subject would also give freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in the study. Patients will be randomly divided into two groups as follows: GROUP A: Tilvak Kshara Application of Kshara: As per required Duration of treatment: 12 Days 4 Settings (On every 4th Day) (0th-4th-8th-12th) Observation: for 16 days (0th-4th-8th-12th-16th) GROUP B: Apamarga Kshara Application of Kshara: As per required Duration of treatment: 12 Days 4 Settings (On every 4th Day) (0th-4th-8th-12th) Observation: for 16 days (0th-4th-8th-12th-16th) The patients will assess on the following parameter and the relevant data will be collected for analysis 1.Per Rectal Bleeding (Gudagat Raktastrava) 2.Size of pile mass 3.Colour of pile mass 4.Mucous discharge 5.Pain associated with defecation 6.Pruritis Medium of Dissertation: The study will be written in English and Sanskrit words will be used wherever necessary STUDY DESIGN: Open labelled Randomised Controlled Trial DURATION OF STUDY: 18 months after Approval of Synopsis STUDY POPULATION: Patients attending OPD and IPD of Shalya Tantra Department having signs and symptoms of Abhyantar Arsha (Internal Haemorroids). It is estimated based on the effect of therapy of Apamarga Kshara application on management of Abhyantar Arsha (Internal haemorrhoids) reported in published article [Ref. Sudarmi K, Dudhamal TS. Comparative clinical study of Apamarga Kshara application, infrared coagulation and Arshohara Vati in the management of Arsha (1st and 2nd degree Hemorrhoids). Ayu. 2017 Jul-Dec;38(3-4):122-126. doi: 10.4103/ayu.AYU_94_17. PMID: 30254391; PMCID: PMC6153910.] with following assumptions: 1. % of effect of therapy of Apamarga Kshara application in the management of Arsha (1° and 2° haemorrhoids) – 87.5% 2. % of effect of therapy of Tilvak Kshara application in management of Arsha (1° and 2° haemorrhoids) – 89% 3. Proportion in standard treatment – 0.875 4. Proportion in the new treatment – 0.89 5. Observed/Expected difference in proportion – 0.02 6. Superiority margin in proportion – 0.25 Required sample size per group is 24 Considering 20% drop out or lost from cooperative. Final sample size is 30 per group |