| CTRI Number |
CTRI/2024/07/070730 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Langali kalka lepa and malahara lepa in the Arshas ( piles) |
|
Scientific Title of Study
|
A Control Clinical Study to evaluate the efficacy of langali Kalka lepa and langali malahara lepa in the management of Arshas(2nd degree 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 |
DrAmar Gajkosh R |
| Designation |
Post graduation ( shalya tantra) |
| Affiliation |
Alvas Ayurveda medical College and hospital vidyagiri moodubidrre. |
| Address |
Alvas Ayurveda medical College and hospital, Shalya tantra department,vidyagiri. moodubidrre pin code 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8660180899 |
| Fax |
|
| Email |
amar1998gajakosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Manjunatha Bhat |
| Designation |
Head of department and professor of department of shalya tantra |
| Affiliation |
Alvas Ayurveda medical College and hospital vidyagiri moodubidrre. |
| Address |
Alvas Ayurveda medical College and hospital, Department of shalya tantra, vidyagiri moodubidrre pin code 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8660180899 |
| Fax |
|
| Email |
dmbg2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr manjunatha bhat |
| Designation |
Head of department, professor |
| Affiliation |
Alvas Ayurveda medical College and hospital vidyagiri moodubidrre. |
| Address |
Alvas Ayurveda medical College and hospital vidyagiri moodubidrre pin code 574227
Department - shalya tantra
Room no - 05
Division - ground floor
Division - ground floor
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9686751182 |
| Fax |
|
| Email |
dmbg2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda medical College and hospital vidyagiri moodubidrre India pin code 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Amar Gajkosh R |
| Address |
Alvas Ayurveda medical College and hospital vidyagiri moodubidrre pin code 574227 |
| Type of Sponsor |
Other [For the post graduation research ( 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 Amar Gajkosh R |
Alvas Ayurvedic hospital moodubidrre |
Opd pf Shalya tantra department
Division - ground floor
Room no - 05
Dakshina Kannada
KARNATAKA |
8660180899
amar1998gajakosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas Ayurveda medical College |
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: Langali , Reference: Bhava prakash nighantu-guduchyadi varga , Route: Rectal, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hareethaki choorna , Reference: Bhava prakash nighantu- haritakyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -luke warm water ), Additional Information: -control group will be having hareethaki choorna for 14 days | | 3 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita- sutra sthana 18 th chapter , Procedure details: 1.patient is advised to lie down in lithotomy position
2.Anus and surrounding parts will be cleaned with povidone iodine solution.
3.Under aseptic measures a proctoscope will be introduced into the anal canal after lubricanting it with 2%lignocaine gel and then the obturator will be removed,after noting number, position and condition of pile mass the proctoscope will be removed
4.Then a lubricanted slit proctoscope will be introduced into the anal canal and then the obturator will be removed.Haemorrhoid mass will be protruded through the slit of the proctoscope
5.Langali kalka lepa will be applied on Arshas in group B, which will be retained for 15 minutes and then it will be washed with sterile water.
6.langali Malahara Lepa will be applied on Arshas in Group c, which will be retained for 15 minutes and then it will be washed with sterile water.
Paschat karma
1.patient is asked to lie down in comfortable posture for 15-20 minutes.
2.5 gm of Hareethaki choorna with Luke warm water orally is given at bed time In all the three groups )
(1) Medicine Name: Langali , Reference: Bhava prakash nighantu-guduchyadi varga , Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 2(g), Frequency: od, Duration: 7 Days | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Langali , Reference: Bhava prakash nighantu-guduchyadi varga , Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with clinical features of 2 nd degree Haemorrhoids |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Haemorrhoids that are Thrombosed, Strangulated and Inflamed.
Haemorrhoids with Fissure in ano, Fistula in ano, Rectal polyps, CA rectum, Rectal prolapse, Inflammatory bowel disese, Proctitis, Perianal & Rectal abscess.
Patients having TB, DM, Hypertension, Coagulopathies, HIV, HBsAg positive.
Pregnant women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arshas ( haemorrhoids) size and degree will change And no bleeding and pain and constipation |
0 th day,7 th day ,8 th day ,15th day,30 th day,45 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Constipation , pain , mass per anum, bleeding |
30 th Days & 45 th day |
|
|
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)
|
01/08/2024 |
| 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="2"
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
|
Clinical trial, Randomised controlled,3 group, where langali single drug is used with two different formulation kalka and malahara for lepa over the Arshas which is most common disease in ano rectal disease for 7 days in each group and for control group hareethaki choorna 5grm at bed time is given . Out come is measured by grading the pain, mass degree and constipation. |