| CTRI Number |
CTRI/2025/03/081869 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of Saptaparna and Apamarga Pratisaraneeya kshara in the Abhyantara Arsha |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Saptaparna Pratisaraneeya Kshara and Apamarga Pratisaraneeya Kshara in the Management of Abhyantara Arsha (Hemorrhoids) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti Choudhary |
| Designation |
MS Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
P.G department of Shalya Tantra, Institute for Ayurved studies and research , Shri krishna ayush university , Sector -8 , Umri road , kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7015669085 |
| Fax |
|
| Email |
kirtichoudhary510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kirti Choudhary |
| Designation |
MS Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
P.G department of Shalya Tantra, Institute for Ayurved studies and research , Shri krishna ayush university , Sector -8 , Umri road , kurukshetra
HARYANA
136118
India |
| Phone |
7015669085 |
| Fax |
|
| Email |
kirtichoudhary510@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kirti Choudhary |
| Designation |
MS Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
P.G department of Shalya Tantra, Institute for Ayurved studies and research , Shri krishna ayush university , Sector -8 , Umri road , kurukshetra
HARYANA
136118
India |
| Phone |
7015669085 |
| Fax |
|
| Email |
kirtichoudhary510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies And Research Shri Krishna Ayush University sector 8 umri road Kurukshetra Haryana India 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved studies and research Shri krishna ayush university Sector 8 Umri road kurukshetra Haryana India 136118 |
| Type of Sponsor |
Other [Government ayurvedic college] |
|
|
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 Rajender Singh |
Institute for Ayurved Studies And Research, Shri Krishna Ayush University |
Room no - 104, P.G department of Shalya Tantra, Institute for Ayurved studies and research , Shri krishna ayush university , Sector -8 , Umri road , kurukshetra
Kurukshetra
HARYANA |
9416662761
drrajendersingh1346@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna AYUSH University Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Saptaparna Pratisaraneeya Kshara | (Procedure Reference: Sushruta Chikitsa Sthana 6/4, Procedure details: It is divided into three phases according to trividha karma:
Poorva karma-Preoperative procedure
Pradhana karma-Operative procedure
Pashchata karma-Postoperative procedure
POORVAKARMA (Pre- Operative):
Written informed consent will be taken.
PC Enema will be given.
All vitals parameter will be examined.
Patient will be asked to lie in lithotomy position.
PRADHANA KARMA (Operative procedure):
Patient will be placed in lithotomy position; painting will be done by using Antiseptic solution.
Per rectal examination will be done & slit proctoscope will be inserted to visualize the internal piles.
Wet cotton or gauze piece will be place above the base of internal piles to prevent the leakage of Kshara to the healthy tissues. Internal piles will be inspected & dried with gauze piece, Kshara will be applied on the affected piles by a spatula.
Kshara will be allowed to absorb in the piles till 100 counting (depend on the nature of the tissue, maximum time up to 2 minutes shall be allowed). Soon after Samyak Dagdha Lakshana is observed (Pakva Jambu Phala appearance on the pile site) then part should be washed by citrus juice (Nimbu).The procedure shall be repeated to the other piles with the same protocol.
PASHCHATA KARMA (Post-Operative):
The patient will be shifted to the IPD for monitoring vitals & allowed to rest in supine position for 30 minutes & will be observed for any adverse effects. Patient will be advised to take plenty of fluids & high bulk diet. Sitz bath with hot water for 15 minutes twice daily. Isabgol husk 1tsp with lukewarm milk at night.
Kshara Karma will be given at the interval of one week for a maximum of four sessions if required.)
| | 2 | Comparator Arm | Procedure | - | Apamarga Pratisaraneeya Kshara | (Procedure Reference: Sushruta Chikitsa Sthana 6/4 , Procedure details: It is divided into three phases according to trividha karma:
Poorva karma-Preoperative procedure
Pradhana karma-Operative procedure
Pashchata karma-Postoperative procedure
POORVAKARMA (Pre- Operative):
Written informed consent will be taken.
PC Enema will be given.
All vitals parameter will be examined.
Patient will be asked to lie in lithotomy position.
PRADHANA KARMA (Operative procedure):
Patient will be placed in lithotomy position; painting will be done by using Antiseptic solution.
Per rectal examination will be done & slit proctoscope will be inserted to visualize the internal piles.
Wet cotton or gauze piece will be place above the base of internal piles to prevent the leakage of Kshara to the healthy tissues. Internal piles will be inspected & dried with gauze piece, Kshara will be applied on the affected piles by a spatula.
Kshara will be allowed to absorb in the piles till 100 counting (depend on the nature of the tissue, maximum time up to 2 minutes shall be allowed). Soon after Samyak Dagdha Lakshana is observed (Pakva Jambu Phala appearance on the pile site) then part should be washed by citrus juice (Nimbu). The procedure shall be repeated to the other piles with the same protocol.
PASHCHATA KARMA (Post-Operative):
The patient will be shifted to the IPD for monitoring vitals & allowed to rest in supine position for 30 minutes & will be observed for any adverse effects. Patient will be advised to take plenty of fluids & high bulk diet. Sitz bath with hot water for 15 minutes twice daily. Isabgol husk 1tsp with lukewarm milk at night.
Kshara Karma will be given at the interval of one week for a maximum of four sessions if required.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18 years to 65 years.
Patients of Arsha (2nd and 3rd degree internal piles).
The Patient who are willing to give consent for treatment. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 65 years.
Patients contraindicated for Kshara Karma.Infected/Inflamed/Thrombosed Piles.
Arsha associated with one or more of the following problems:
Pregnancy
Ano-rectal and other malignancy
Rectal prolapse
Fissure and Fistula-in-ano.
Diagnosed case of Acute/chronic ulcerative colitis
Diagnosed case of Crohn’s disease
Hemorrhoids of 4th degree and Bahya Arsha (External piles)
Diagnosed case of HIV, HBsAg & VDRL Positive cases
Tuberculosis
Uncontrolled hypertension & diabetes mellitus
Other metabolic disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the comparative efficacy of Saptaparna Pratisaraneeya Kshara and Apamarga Pratisaraneeya Kshara in the management of Abhyantara Arsha. |
1-4 sittings (As required)
1st 7th 14th 21st day- during treatment
28th 35th 42nd day- post treatment follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Symptoms of Abhyantara Arsha and elevating the standard of living the life of patients. |
21 days |
|
|
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 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="0"
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 recognized as one of the eight Mahagadas according to Acharya Sushruta due to its unique characteristics and its positioning within the traditional texts. Its etiology and management are extensively discussed in classical literature. Mandagani, or impaired digestive fire, is identified as the primary causative factor of Arshas, leading to constipation and the prolonged retention of waste material in the anal canal, ultimately resulting in the development of Hemorrhoids. Acharya Sushruta described a comprehensive therapeutic approach for managing Arsha, encompassing four main modalities: Bheshaja karma (medicinal treatment), Kshara karma ( application of caustics), Agnikarma ( utilization of heat), and Shastra karma ( surgical intervention). Kshara, an alkaline substance derived from the ashes of medicinal plants, constitutes a less invasive alternative compared to surgical procedures like Shastra Karma and thermal cautery such as Agnikarma. Kshara is highly valued for its many uses, including excision (Chedana), incision (Bhedana), scraping (Lekhana), and its effectiveness in pacifying all three doshas (Tridoshaghna). It works in hard-to-reach areas where typical methods might not be effective. Kshara Karma, an Ayurvedic procedure involving the application of an alkaline paste, has been used for centuries to treat Hemorrhoids. Kshara Karma is less invasive compared to conventional surgical methods like Hemorrhoidectomy. It involves minimal bleeding, shorter recovery times, and can be performed on an outpatient basis, making it a potentially preferable option for many patients, For patients who are not candidates for surgery due to age, comorbidities, or other risk factors, Kshara Karma can offer a viable alternative. Kshara Karma is generally more cost-effective than surgical options. Understandings its economic benefits can make it an attractive option for healthcare systems, especially in resource-limited settings. Apamarga Kshara has been used traditionally for a long time, but exploring other Ksharas can offer new therapeutic benefits. Embracing different Ksharas can provide diverse healing properties and enhance the overall efficacy of treatments in Ayurveda. |