| CTRI Number |
CTRI/2025/07/092039 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC TREATMENT FOR HEMARRHOIDS |
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Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KUTAJA PRATISARANIYA KSARA AND KASISADI TAILA IN THE MANAGEMENT OF ARSAS HEMORROHOIDS |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Basammagari Amarnath |
| Designation |
Post graduate scholar |
| Affiliation |
S.V.Ayurvedic College and Hospital |
| Address |
Room no.41, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
9652205100 |
| Fax |
|
| Email |
dramarnath006@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
T Srinivasa rao |
| Designation |
Associate Professor |
| Affiliation |
S.V.Ayurvedic College and Hospital |
| Address |
Room no.45, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh
Chittoor ANDHRA PRADESH 517507 India |
| Phone |
9440601161 |
| Fax |
|
| Email |
dr.srinivasayu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
T Srinivasa rao |
| Designation |
Associate Professor |
| Affiliation |
S.V.Ayurvedic College and Hospital |
| Address |
Room no.45, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh
ANDHRA PRADESH 517507 India |
| Phone |
9440601161 |
| Fax |
|
| Email |
dr.srinivasayu@gmail.com |
|
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Source of Monetary or Material Support
|
| S.V.Ayurvedic College and Hospital
Tirupati, Chittor, Andhra Pradesh
517507
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Primary Sponsor
|
| Name |
S.V.Ayurvedic College and Hospital |
| Address |
Tirupati, Chittor, Andhra Pradesh
517507
|
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Basammagari Amarnath |
S.V.Ayurvedic Hospital |
Room no.41, second floor, PG department of Shalya tantra, S.V.Ayurvedic College and Hospital, Tirupati, Chittor, Andhra Pradesh
Chittoor ANDHRA PRADESH |
9652205100
dramarnath006@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of TTDs S V Ayurvedic College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: Bhaisajya Ratnavali, Arshoroga Chikitsa prakaram chapter, Procedure details: It will be conduct according to the principle of trividha karma Poorva karma pre operative procedure Routine investigations will be check Fitness of patient will be check Written in form consent of patient `will be taken Shaving & cleaning of the peri anal region will be done. Pradhana karma: The patient will be laid down in lithotomy position The perianal part will be painted & draped with sterilized cut sheet Then lubricate the proctoscope, with the cut aperture will be introduced in the anal canal The pile mass is fixed at the suitable place into the aperture. After cleaning the pile mass with gauze piece, then Application of kaseesadi taila pichu dharana Paschat karma Ano rectal region will be applied with sterile gauze piece and pads ) (1) Medicine Name: Kāsīsadi taila , Reference: Bhaisajya Ratnavali, Arshoroga Chikitsa prakaram chapter, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushrut samhit , Cikitsā sthāna 6th chapter arsha chikitsitam 4th shloka, Procedure details: It will be conduct according to the principle of trividha karma Poorva karma: [ pre operative procedure] •Routine investigations will be check •Fitness of patient will be check •Written in form consent of patient will be taken •Shaving and cleaning of the peri anal region will be done. Pradhana karma: •The patient will be laid down in lithotomy position •The perianal part will be painted and draped with sterilized cut sheet •Then lubricate the proctoscope, with the cut aperture will be introduced in the anal canal The pile mass is fixed at the suitable place into the aperture. •After cleaning the pile mass with gauze piece, then apply the Kuṭaja Kṣāra. •Applied Kṣāra will be keep for 100 mātrā kāla. •After the application of the Kṣāra the pile mass changed to pakwajambuphala Varna [ripen fruit of Jamun fruit].it indicates the Samyak Kṣāra dhagda lakshana. •The Kṣāra is wash out with the nimbu swarasa. Paschat karma: • Madhu and ghrita will be applied to overcome the gudadāha [burning sensation]. • Ano rectal region will be applied with sterile gauze piece and pads. )
) (1) Medicine Name: Kuṭaja Kṣāra,, Reference: Suśruta saṃhita. Sutrasthāna 11th chapter ksharapaka vidi adhyayam 11th shloka ,, Route: Rectal, Dosage Form: Kshara, Dose: 10(g), Frequency: od, Duration: 3 Days |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having signs and symptoms of Arsas
2.Patients with age ranging from 18 years to 60 years with irrespective of gender
3.Patients having II and III degree Hemorrhoids |
|
| ExclusionCriteria |
| Details |
1.Concomitant ano rectal conditions like Fistula in ano, Fissure in ano
2.ulcerative colitis
3.Carcinoma of rectum
4.Pregnant women
5.Portal hypertension
6.Chronic kidney diseases
7.Tuberculosis on Anti tuberculosis treatment
8.Inflammatory bowel disease |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the Efficacy of Kutaja Pratisaraniya Ksara with reference to objective and subjective parameters |
At baseline, Every week for 2 weeks and after 2 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Efficacy of Kutaja Pratisaraniya Ksara & Kasisadi Taila |
At baseline, after 15 days,
after 2 months |
|
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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" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
11/08/2025 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dramarnath006@gmail.com].
- For how long will this data be available start date provided 28-08-2025 and end date provided 28-01-2083?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
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Brief Summary
|
Arshas has become one of the commonest health problems of the modern society. It is the foremost common disease among Anorectal disorders and the area of concern even since the Vedic periods. This disease causes discomfort and severe pain to the patient which creates problems in his daily routine. Because of its severity it is considered as one among Ashta Mahagada. As it is difficult to treat completely and because of its Svabhava which create problems to the patients as an enemy the name Arshas has been given. The food habits and life styles of modern man also added to the increase in the rate of incidence of Arshas.
Present time is the era of changing food, sedentary life style and mental stress, all these factors disturbs the digestive system resulting into many diseases. Among them one important group is Ano-rectal diseases and Arshas is one among them. Arshas have been known to mankind since long time and one of the commonest disease to effect the human being. One of its prime etiological factor is Mityaahara-Vihara. When we observe the today’s patients, we understand that they want quick relief but at the same time not interested to undergo surgery that may give severe post-operative pain. In such conditions the alternative is Kshara Karma procedure that gives relief and the pain is insignificant.
The great Indian Surgeon Susrutha known as father of surgery has described Arshas in Susrutha samhita Nidana stana[5] 2nd chapter and its chikitsa in Chikitsa sthana 6th chapter . He considered Arshas as one of the Astha Mahagadas means diseases which are very difficult to treat. Arshas causes troublesome pain for patient like enemy, which afflicting mankind for thousands of years[7]. According to Madhavakara, the disease which kills a man like an enemy is called Arshas. The present lifestyle is adding to the prevalent rate of this disease.
This condition can be correlated with Haemorrhoids in modern medical science, in which dilated veins within the anal canal in the sub epithelial region formed by radicals of superior, middle and inferior rectal veins. Haemorrhoids are engorgement of the Haemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse and discharge.
Depending on grade of prolapse , Haemorrhoids can be divided into 4 degrees :
1. First degree : Haemorrhoids within that may bleed but does not come out of anus.
2. Second degree : Haemorrhoids come out only during defecation and gets reduced
Spontaneously.
3. Third degree : Haemorrhoids come out only during defecation and do not return by themselves, but need to replaced manually and then they stay reduced.
4. Fourth degree : Haemorrhoids are permanently prolapsed with great discomfort and feeling of heaviness in the rectum[1].
It is manifested due to improper diet, prolonged standing and faulty habits of defecation causing derangement of tridoshas, mainly vata dosha. Vitiated doshas localizes in gudhavali pradhana dhamani and mamsadhara kala and vitiates twak, mamsa and raktha, resulting in annavaha srotho dushti. These vitiated doshas moves in downward direction, reaches guda and produces sprouts of muscle in gudavali. These sprouts are called Arshas.
In Charaka samhitha, Charakaacharya has given more emphasis on the conservative treatment and prescribed suitable diet regimen with drugs, further he also advised kshara karma treatment for different types of arshas.
In Sushruta Samhita, Acharya Susrutha has mainly narrated the four types of treatment modalities in sushruta samhitha chikitsa sthana in Arshachikitsa for successful management of Arshas viz., Bhesaja [Internal and external medications], Shastra [Surgical methods], Kshara [Caustic cauterization], and Agnikarma [Thermal cauterization].[6]
Susrutha, while describing the preparation of kshara, emphasized on the procedure of kshara karma and mentioned that arshas which are Mridu,Prasrutha,Avagadha,Uchrita should be treated only by kshara karma. The effect of kshara is praised so much that it can replace sastrakarma as it does the functions of Chedana, Bhedana, Lekhana karmas without using the sastras[surgical instruments]. Among the four treatment modalities in Arshas mentioned by susrutha, kshara karma and Agnikarma are considered as para-surgical procedures.
Despite of many more modern treatments like Rubber band ligation, Sclerotherapy, Photocoagulation, Cryosurgery, Haemorrhoidectomy, etc., Ayurveda is well known for the treatment of Arshas for its negligible rate of recurrence, cost effective, less chances of pain, Haemorrhage, infection and anal incontinence.
In Sushruta Samhita, Sutrastana “Ksharapakavidi adyaya” mentioned 23 kshara dravyas, Kutaja is the first one among them[4]. Here I would like to prepare kshara with KUTAJA (bark), In this clinical study kutaja kshara will be take into consideration for local application directly on the arshas. |