| CTRI Number |
CTRI/2025/11/097993 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative clinical study to check the role of laser ablation followed by Sapthacchada Pratisaraneeya Kshara Karma in the management of 2nd and 3rd degree internal haemorrhoids - A hybrid technique |
|
Scientific Title of Study
|
A Randomized Open Label Comparative Clinical Study To Evaluate The Role Of Laser Ablation Followed By Sapthacchada Pratisaraneeya Kshara Karma In The Management Of 2nd & 3rd Degree Internal Haemorrhoids - A Hybrid Technique |
| 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 Darshan Patil |
| Designation |
PG Scholor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Shalya Tantra Sri Sri College of Ayurvedic Science and Research 21st KM Kanakapura road Udayapura Post Bengaluru 560082
Banglore
India
Bangalore
KARNATAKA
560082
India |
| Phone |
7349759489 |
| Fax |
|
| Email |
patildarshan652@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KM Sweta |
| Designation |
Professor & HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Shalya Tantra Sri Sri College of Ayurvedic Science and Research 21st KM Kanakapura road Udayapura Post Bengaluru 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9902521973 |
| Fax |
|
| Email |
dr.swetatyagi1882@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshan Patil |
| Designation |
PG Scholor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department of PG Studies in Shalya Tantra Sri Sri College of Ayurvedic Science and Research 21st KM Kanakapura road Udayapura Post Bengaluru 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
7349759489 |
| Fax |
|
| Email |
patildarshan652@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research Hospital 21st KM Kanakapura road Udayapura Post Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Darshan Patil |
| Address |
Department of PG Studies in Shalya Tantra Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road Udayapura Post Bengaluru 560082 |
| Type of Sponsor |
Other [] |
|
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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 Darshan Patil |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of PG Studies In Shalya Tantra Sri Sri College of Ayurvedic Science and Research 21st KM Kanakapura road Udayapura Post Bengaluru 560082
Bangalore
KARNATAKA |
7349759489
patildarshan652@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
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:K00-K95||Diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Laser Ablation | The patient will be taken in lithotomy position, Painting and draping will be done to the perianal region. Appropriate Anesthesia according to presentation of the condition will be infiltrated, manual anal dilatation will be achieved. Lubricated proctoscope will be introduced into the anal canal. The approach will be started via a small incision at the mucocutaneous junction. The laser fiber is introduced into the haemorrhoidal plexus taking into consideration that the optic fiber should be parallel to the anal canal to avoid injury or burn of the mucosa or internal sphincter. Using a 1470 nm diode laser, laser shots are delivered through the optic fiber in a pulsed fashion for the favorable degeneration of the periarterial healthy tissue. The limits of shrinkage can be controlled by the duration and power of the laser beam. Via the optic fiber, laser shots are generated at a power of (120-140 joules) with the duration of 7 seconds each shot followed by a pause of 1 second causes shrinkage of tissues approximately up to the depth 5mm. This procedure is repeated for each haemorrhoid. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saptacchada, Reference: Bhavprakasha Nigantu, Route: Rectal, Dosage Form: Kshara , Dose: 1(NA), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 1 Days, Reference: No, Route: NA, Dosage Form: Kshara , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Intervention Arm | Procedure | - | Laser ablation followed kshara karma | (Procedure Reference: NA, Procedure details: The patient will be taken in lithotomy position, Painting & draping will be done to
the perianal region. Appropriate Anaesthesia according to presentation of the condition will be
infiltrated, manual anal dilatation will be achieved. Lubricated proctoscope is introduced into the anal canal. This approach will be started via a small incision at the mucocutaneous junction. The laser fiber is introduced into the haemorrhoidal plexus taking into consideration
that the fiber should be parallel to the anal canal to avoid injury or burn of the mucosa or internal sphincter. Using a 1470 nm diode laser, laser shots are delivered through the optic fiber in a pulsed fashion for the reduction of favorable degeneration of the periarterial healthy tissue. The limits of shrinkage can be controlled by the duration & power of the laser beam. Via the optic fiber, laser shots will be generated at a power of (80-100 joules) with the
duration of 7 seconds each shot followed by a pause of 1 second causes shrinkage of tissues approximately up to the depth 5mm. The depth of shrinkage is regulated by the power & duration of the laser beam. Later, Saptacchada Madhyama Pratisaraneeya Kshara is applied over the area of ablation. Considered covering the healthy anal mucosa with a cotton swab. Then the pile mass is cleaned with Nimbu Swarasa. The colour of pile mass turns to Pakva Jambu Phala Varna. This procedure is repeated for each haemorrhoid. Later, packing will be done & patient will be shifted to the ward in
haemodynamically active state.)
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects Aged Between 21 to 60 Years irrespective of Gender Religion Occupation Socioeconomic status and Educational Status
2.Subjects Who Fulfills The Diagnostic Criteria of 2nd & 3rd Degree Internal Haemorrhoids |
|
| ExclusionCriteria |
| Details |
1.Haemorrhoids associated with Rectal Prolapse Fistula in ano Thrombosed Pile Mass
2.Subjects Contraindicated For Kshara Shastra and Agnikarma
3.Haemorrhoids Associated With Carcinoma of Rectum and Anal canal
4.Subjects With Other Systemic Illness Like Tuberculosis Ulcerative colitis Chrons disease |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
Significant reduction in the
1.Postoperative pain bleeding and discomfort
2.Postoperative complications such as stenosis & Fecal incontinence
3.Size of pile mass
Seconday Outcome
1.Lesser time duration of healing
2.Minimal hospital stay
3.Very low rate of recurrence due to dual outcome of both Kshara Karma and Laser Ablation |
0th 3rd 5th 7th 14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Lesser Time Duration Of Healing
2.Minimal Hospital Stay
3.Very Low Rate Of Recurrence Due To Dual Outccome Of Both Kshara Karma and Laser Ablation |
28th & 35th day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
|
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
|
This Study Has been Taken Up To Evaluate The Role Of Laser Ablation Followed By Saptacchada Pratisaraneeya Kshara Karma In The Management Of 2nd & 3rd Degree Internal Haemorrhoids a Hybrid Technique
Null Hypothesis H0 The Efficacy Of Hybrid Technique Is Better Than Kshara Karma & Laser Ablation Individually H1 The Efficacy Of Kshara Karma Is Better Than Hybrid Technioque & Laser Ablation Individually H2 The Efficacy Of laser Ablation is Better Than Hybrid Technique & Kshara Karma Individually. |