| CTRI Number |
CTRI/2024/11/076516 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO KNOW THE ALKALI EFFECT ARKA KADALI AND APAMARGA PRATISARANIYA PROCEDURE IN INTERNAL HAEMORRHOIDS |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF ARKA KADALI AND APAMARGA PRATISARANIYA KSHARAKARMA IN THE MANAGENMENT OF ABHYANTARA ARSHA vis a vis 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.DURAGAPPA HARIJANA |
| Designation |
PROFESSOR |
| Affiliation |
Government Ayurveda Medical College.Bangalore. |
| Address |
GOVERNMENT AYURVEDA MEDICAL COLLEGE.BANGALORE-560009
Government Ayurveda Medical College , Bangalore -560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9886102933 |
| Fax |
|
| Email |
durgeshhabalakatti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathiksha V |
| Designation |
2nd year Pg scholar |
| Affiliation |
Government Ayurveda Medical College.Bangalore. |
| Address |
Government Ayurveda Medical College Bangalore -560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9483212511 |
| Fax |
|
| Email |
prathikshav157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathiksha V |
| Designation |
2nd year Pg scholar |
| Affiliation |
Government Ayurveda Medical College.Bangalore. |
| Address |
Government Ayurveda Medical College and Banglore -560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9483212511 |
| Fax |
|
| Email |
prathikshav157@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE-560009 |
|
|
Primary Sponsor
|
| Name |
Dr PrathikshaV |
| Address |
Government Ayurveda Medical College Bangalore-560009 |
| Type of Sponsor |
Other [] |
|
|
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 PRATHIKSHA V |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
DEPARTMENT OF SHALYATANTRA,OPD NO 10.NEAR MAJESTIC, DHANWANTARI ROAD BANGALORE-560009
Bangalore
KARNATAKA |
9483212511
prathikshav157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurveda Medical College Bangalore |
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 | - | pratisAraNIya-kShAraH, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¥€à¤¯-कà¥à¤·à¤¾à¤°à¤ƒ | (Procedure Reference: Sushruta, Procedure details: Purvakarma(Pre operative procedure):
The procedure of Arka kadali kshara application will be explained to the patients.
A written consent is taken before the procedure.
Part preparation will be done.
Vitals will be recorded.
Inj.T.T.0.5ml will be given IM.
Inj.xylocaine test dose will be given.
Proctoclysis enema will be given before surgery to clear or empty the bowel.
Pradhana karma(Operative procedure):
The patient will be taken in lithotomy position & the perianal area will be cleaned with aseptic solutions & draping will be done. Local anesthesia will be given with inj.xylocaine & manual anal dilatation upto 4finger will be done. Then a lubricated Proctoscope will be introduced in the anal canal. Position of pile mass will be noted. Then slit proctoscope will be introduced & skin around pile mass will be pulled laterally with Alli’s tissue holding forceps to get better view of haemorrhoids. The anal mucosa around the pile mass will be covered with wet cotton swabs to prevent spilling of kshara on it. The pile mass will be gently rubbed with gauze. Arka-kadali kshara will be applied over pile mass, & opening of proctoscope will be closed for shata matra kala with palm. After this process, the Kshara will be washed with Jambeera Swarasa followed by normal saline. After application of the Kshara the pile mass changed to bluish-black (pakva Jambu phalvat ) in appearance. If there is no change in colour of pile mass, kshara pratisarana will be repeated till the pile mass turns in to blusish-black colour. Proctoscope & cotton swab will be removed. Anal canal will be packed with sterile pads. Dressing will be done & patient will be shifted to ward.
Same procedure will be followed for other pile mass if present.
Pashchat karma(Postoperative procedure):
Anal pack will be removed after 6 hours.
Analgesics will be administered according to the need.
From next day onwards patient will be advised to take warm sitz bath for 15 minutes twice
daily after passing stool.
Jatyadi taila pichu/jatyadi taila poorana for 7 days will be advised.
Triphala choorna/haritaki choorna in dose of 1 tsp will be given at night with luke warm
water as laxative.
Triphala guggulu 1-1-1A/F
Gandhaka rasayana 1-1-1A/F
High residue diet advised to the patient.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1Subjects with arshas which are mridu,prasrita,avagada,uchrita.
2Subjects with raktasrava,gudakandu,gudasrava,arshankura
3Subjects with 1st and 2nd degree hemorrhoids. |
|
| ExclusionCriteria |
| Details |
1Subjects with systemic diseases
2Subjects with fecal incontinence
3pregnant and lactating women
4Contraindicated for ksharakarma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief of symptoms
Reduction in size of hemorroidal mass. |
Oth day (treatment),7th day,14th day ,21st day (follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enhance the quality of life. |
Oth day (treatment),7th day,14th day ,21st day (follow up) |
|
|
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)
|
15/11/2024 |
| 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="1"
Months="6"
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
|
Arsha is a protrusion of mamsa which obstructs gudamarga and torture the person like an enemy. Arsha is one among Ashta mahagadha as it is deergakalanubandi and dushchikitsya in nature and involves guda pradesha which is sadyo prana hara marma. Etiology being indulging in mithya ahara and vihara produces mandagni, and later aggravated doshas enters guda and vitiates gudavalis to form mamsapraroha called as Arsha". Ksharakarma is one of the four treatment modalities mentioned in chikitsa of Arsha. It is indicated in the Arshas which are mridu, prasrita, avagada, uchchhrita Haemorrhoids are dilated veins within the anal canal in sub-epithelial region formed by radical of superior, middle, inferior rectal veins.Normally anal cushions helps in maintenance of the anal continence and sliding of anal cushion abnormally is called as Haemorroids". Globally incidence ranges from 50-80% and in India it affects around 75% of population" Internal pile is a natural consequences of adaptation of erect posture of mankind Clinical features are bleeding. mass per anus, prolapsed, discharge, pruritus-ani, pain Treatment includes more liquid intake and fiber diet. Medical measures are local applications, sitzbath, laxatives, analgesics. Parasurgical measures includes Sclerotherapy, Banding, Cryotherapy, IRC, Laser therapy, DGHAL. Surgical measures are Hemorrhoidectomy, Staple Haemorrhoidectomy These interventions have complications like Hypochondric pain, pelvic abscess, severe pain, secondary hemorrhage, ulceration, incontinence, injury to sphincter, retention of urine, anal stricture, anal fissure and recurrence is also common. Hence there is always a need for cost effective, simple treatment for Arshas. Pratisaraniya teekshna ksharakarma has very low rate of recurrence and it causes less pain, less bleeding, less chances infection with no anal incontinence. Arka and Kadali are mentioned as kshara dravys by sushruta in kshrapakavidiadyaya. Arka has gunas like vranaropana, vranashodana, kandugna, kaphashamana arshogna Kadali kanda has gunas like kaphapittahara, raktashamaka. Hence combination of these two Kshara Dravyas i.e., Kadali and Arka is selected in the present study in the management of Abhyantara Arshas by Pratisarana kshara karma. |