| CTRI Number |
CTRI/2023/08/056160 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| 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 trail to study two pratisarneeya kshara , jala yukta nimba pratisarneeya kshara and gomutra yukta nimba pratisarneeya kshara in patients of abhyantara arshas(internal haemorrhoids). |
|
Scientific Title of Study
|
Comparative clinical study on the effectiveness of jala yukta nimba pratisarneeya kshara and gomutra yukta nimba pratisarneeya kshara in the management of abhyantara arshas |
| 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 Rahul Dogra |
| Designation |
Pg scholar- Department of Shalyatantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital, BM Road Thanniruhalla
Hassan, Karnataka
Hassan KARNATAKA 573201 India |
| Phone |
8360630523 |
| Fax |
|
| Email |
dograrahul886@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal and Professor- Department of Shalyatantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital, BM Road Thanniruhalla
Hassan, Karnataka
Hassan KARNATAKA 573201 India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal and Professor- Department of Shalyatantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital, BM Road Thanniruhalla
Hassan, Karnataka
Hassan KARNATAKA 573201 India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,BM Road, Thanniruhalla, Hassan, Karnataka,India - 573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Dogra |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan |
Department of shalya tantra opd no 11( ano rectal opd ) .
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,BM Road, Thanniruhalla, Hassan, Karnataka, India - 573201 Hassan KARNATAKA |
8360630523
dograrahul886@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan , Karnataka 573201 |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•रà¥à¤® | (Procedure Reference: Sushruta samhita, Procedure details: The Participant will be taken to lithotomy position. The part is cleaned with aseptic solutions. Draping done before local anesthesia administration. Dilatation of anal canal after lubricating the finger with lignocaine jelly. Arshoyantra smeared with Taila is to be introduced into the anus. Assess the Haemorrhoids. The pile mass should be gently cleaned with cotton swab with Normal Saline. Then the gomutra Yukta Nimba Kshara will be applied with the help of Darvimukha Shalaka. After applying th)
| | 2 | Comparator Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•रà¥à¤® | (Procedure Reference: Sushruta samhita, Procedure details: The Participant will be taken to lithotomy position. The part is cleaned with aseptic solutions. Draping done before local anesthesia administration. Dilatation of anal canal after lubricating the finger with lignocaine jelly. Arshoyantra smeared with Taila is to be introduced into the anus. Assess the Haemorrhoids. The pile mass should be gently cleaned with cotton swab with Normal Saline. Then the jala Yukta Nimba Kshara will be applied with the help of Darvimukha Shalaka. After applying the k)
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Arshas which are of Mridu(soft), Prasrita(spreaded), Avagadha(deep), Uchrita (elevated).
2. First and second degree internal Haemorrhoids
3. Participants above the age of 18 years and below 70 years irrespective to gender, religion and socio-economic status. |
|
| ExclusionCriteria |
| Details |
1. Participants with carcinoma of rectum and anal canal
2. External Haemorrhoids and interno-external Haemorrhoids
3. Patients with other systemic illness like IBS, Ascites, HBsAg positive & HIV positive.
4. Uncontrolled Diabetes (HbA1C >8).
5. Pregnant and lactating women.
6. Participants with impaired cardiac, renal and hepatic function. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Size of pile mass
2. Colour of Haemorrhoids
|
28 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Constipation
3. Bleeding |
28 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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="2" 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
|
The disease which gives maximum trouble to mankind like an enemy is Arshas (Haemorrhoids). Sedentary life style, busy schedule of work, stress and bad food habits gives arises to Arshas. The primary etiological factor for the same is Mandagni. Arshas which is compared to Haemorrhoids in the contemporary science is the commonest Ano-rectal condition seen in the practice of proctology. The dilated veins within the anal canal in the sub-epithelial region formed by radicles of superior, middle and inferior rectal veins are called as Haemorrhoids. Incidence of this disease can be traced since Vedic period. Its incidence increases with advancing age, at least 50% of people over the age of 50 years have some degree of Haemorrhoidal symptoms. Nowadays most of the persons suffer from any one of the complaints of piles during their life time. In India 75% of population is estimated to be suffering from Haemorrhoids. Among this almost half million’s population are experiencing condition’s that are related to Haemorrhoids. Usually many are not aware that they have a symptom associated to this condition. According to modern surgery Haemorrhoids, which are not treated properly or neglected, may lead to complication such as strangulation, thrombosis, portal pyaemia, suppuration, haemorrhage etc. In modern medical sciences Haemorrhoids are treated with injection-Sclerosant therapy, Barron’s bandage, Cryosurgery, Infrared coagulation, DGHAL, Stapled haemorrhoidopexy second degree Haemorrhoids mainly treated with Barron’s band ligation and early second degree Haemorrhoids treated with injection therapy. Unfortunately, all these techniques have got one or the other types of limitation. The ancient medical authorities like Acharya Charaka and Acharya Sushruta both have described four types of measures for the treatment of Arshas. These are Bheshaja, Kshara, Agni and Shastra. As per the available treatment modalities of Arshas, the Kshara Karma modality is the best one, taking into the consideration its convenience, easy adoptability, cost effectiveness and curative results. While going through the chapter of treatment of the disease Arshas, it becomes quite evident that Kshara Karma has been indicated for all the varieties of Arshas, that even the pedunculated and Arshas of a very big size can also be successfully treated with the help of Kshara Karma. Hence the repeated advocacy of Kshara Karma by almost all the ancient Acharya in the disease Arshas has given an inspiration to work on the disease Arshas with the help of Pratisarneeya Kshara, because of its simple technique and it has important properties like Chedana, Bhedna, Lekhana. Nimba has Krimighna and Arshoghna properties and have chemical constituents like nimbidin, nimbidol, sodium-nimbinate which helps in antimicrobial action. Anal canal is prone to contamination during postoperative period because of which there will be delaying of Ksharadagdha Vrana Ropana. Nimba is abundantly available, with a single plant we can get a large amount of Kshara. So, Nimba is selected for the Pratisarneeya Kshara in Abhyantra Arshas. Nimba Pratisarneeya Kshara having properties like Sheeta Veerya, Tikta and Kashaya Rasa acts on haemorrhoids by cauterising the pile mass, due to its Teekshna Kshara Guna and coagulates protein in haemorrhoidal plexus. Gomutra is important part of Indian tradition. It is not only holy but also has various important medicinal uses. Classical treatises in Ayurveda that is Charaka, Sushruta and Vagbhata Samhita has described Ashta mutra (eight types of urine) along with their properties, indication and uses. Cow urine is one of them and considered as best. Cow urine is one of the five contents of Panchagavya which obtain from cow (urine, milk, ghee, curd and dung). Wound infection is a common cause of wound chronicity. It prolongs the inflammatory phase by increasing the production of inflammatory cytokines which lead to additional tissue destruction as well as delays wound collagen synthesis. Therefore, preventing wound infection would hasten process by promoting collagen synthesis. Various studies have demonstrated that cow urine (Gomutra), as well as its distillate, has antibacterial and antifungal activity against various strains of pathogens . Till now, studies have been carried out by the use of Jala Yukta Apamarga, Chitraka, Nimba, Aragwadha and Palasha Kshara in various centers in India but less attention has been paid to Gomutra Yukta Kshara. So, considering the above points it is very much essential to conduct a comparative study on Jala Yukta and Gomutra Yukta Nimba Pratisarneeya Kshara Karma. |