| CTRI Number |
CTRI/2024/08/072482 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of Saindhavadya taila purana over Kasisadi taila purana in the management of Abhyantara arshas (Internal haemorrhoids) |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the effect of Saindhavadya taila purana over Kasisadi taila purana in the management of Abhyantara arshas (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 Mallikarjun Kokatanur |
| Designation |
PG Scholar- Department Of Shalya Tantra |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of Post Graduate studies in Shalya Tantra
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital
Koppal
KARNATAKA
583231
India
Koppal
KARNATAKA
583231
India |
| Phone |
8861167548 |
| Fax |
|
| Email |
mallikarjunkokatanur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B S Savadi |
| Designation |
Professor and HOD - Department of Shalya Tantra |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of Post Graduate studies in Shalya Tantra
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital
Koppal
KARNATAKA
583231
India
Koppal
KARNATAKA
583231
India |
| Phone |
9845646885 |
| Fax |
|
| Email |
savadi.savitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B S Savadi |
| Designation |
Professor and HOD - Department of Shalya Tantra |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of Post Graduate studies in Shalya Tantra
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital
Koppal
KARNATAKA
583231
India
Koppal
KARNATAKA
583231
India |
| Phone |
9845646885 |
| Fax |
|
| Email |
savadi.savitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
|
|
Primary Sponsor
|
| Name |
Dr Mallikarjun Kokatanur |
| Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Gavimath campus, Koppal, Karnataka, 583231 |
| Type of Sponsor |
Other [self Sponsoring] |
|
|
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 Mallikarjun Kokatanur |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal, Karnataka |
Department of Shalya Tantra OPD No 16, Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College, Gavimata campus, Koppal, Karnataka
Koppal
KARNATAKA |
8861167548
mallikarjunkokatanur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Institutional Ethics Committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saindhavadya taila , Reference: Charaka samhita, Chikitsa sthan, 27th chapter, Shloka No. 45-46, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Patients will be administered 10ml of Saindavadya taila in the anal canal by rubber catheter no.09 with 10cc syringe for 07 days. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kasisadi taila, Reference: Sushruta Samhita, Chikitsa sthana, 6th chapter, Shloka No. 12, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Patients will be administered 10ml of Kasisadi taila in the anal canal by rubber catheter no.09 with 10cc syringe for 07 days. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients with Abhyantara arsha [1st and 2nd degree internal haemorrhoids] age between 21 to 65 years of either gender with maximum 3 internal haemorrhoids.
(2) Patients with Hb% more than 8 gm per dl.
|
|
| ExclusionCriteria |
| Details |
(1) External and Thrombosed pile mass.
(2) 3rd and 4th degree Internal haemorrhoids.
(3) Patient with HIV and HBsAg positive.
(4) Patients with Diabetes. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Objective parameter-
Size of Mamsankura [pile mass] ,
Number of Mamsankura [pile mass] |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of-
- Raktasrava (Bleeding)
- Vibandha (Constipation) |
Total Study duration – 21 days.
Treatment duration – 07 days.
Follow up – 14 days.
Assessment days- 1st day [Before treatment]
7th day [After treatment]
14th day [During Follow up 1]
21th day [During Follow up 2]. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/08/2024 |
| 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="8"
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 - NO
|
|
Brief Summary
|
Haemorrhoids are the dilated veins within the anal canal in the sub-epithelial region formed by radicles of the superior, middle and inferior rectal veins. Internal haemorrhoids are those which are within the anal canal and internal to anal orifice. It’s incidence increases as age advances and at least 50%of the people over the age of 50 years have some degree of haemorrhoidal symptoms. The prevalence rate of piles is 4.4% in the world, in about 10 million people. Haemorrhoids may occur at all ages, but are uncommon below the age of 20 years and more than 65 years. The modern modalities of treatment in 1st and 2nd degree internal haemorrhoids are Sclerotherapy, Rubber band ligation and Cryosurgery each procedure has its own complications like in sclerotherapy recurrence rate 15%, hypochondriac pain due to entry of drug into the portal system, ulceration, submucosal abscess etc. In Barron’s banding if applied low into skin it causes severe pain, discomfort, secondary haemorrhage and ulceration. In Cryosurgery after procedure profuse watery and foul smelling discharge which starts within 3 hours of the procedure and lasts for 2 to 4 weeks and recovery is prolonged So, modern science has very little to offer in terms of medical treatment of piles. Arshas is one among the Gudagata vikaras which can be correlated to the Haemorrhoids. According to Acharya Vagbhata, Arshas are mamsankura (protrusion of mamsa) which obtructs Guda marga and torture the person like enemy . It is Deerghakalanubandhi, Dushchikitsa, Tridoshaja and it occurs in Marma sthana, so it is considered one among the Ashta Mahagada . Arshas is manifested due to improper diet, sedentary lifestyle, prolonged standing, irregular sleep habits and Vegadharana which disturbes the digestive system and causes constipation and does dearrangement of tridoshas mainly Vata dosha. Vitiated dosha localizes in Gudavalli, pradhana dhamani and mamsadhara kala which vitiates twak, mamsa, medas and rakta resulting in maha sroto dushti. Arsha which is formed within the Gudoushta (anus) is abhyantara arsha which is associated with symptoms of Mamsankura in guda , Shula, Raktasrava Acharya Sushruta has mentioned four treatment methods for Arshas such as Aushadha, Shastra, Kshara and Agni karma. Among the four modes of treatments mentioned, Aushada causes the least discomfort to the patient psychologically, physically and economically Hence effective management of this condition using an Aushadha is the need of the hour. Acharya Charaka while explaining ’Saindavadya taila’ indications, Arshas and other diseases has been mentioned. So here an attempt is made to evaluate the effect of Saindavadya taila in the form of Guda purana with Kasisadi taila as its efficacy was proved to be effective hence it was taken as control drug in Arshas. |