FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064299 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Apamarga Kshara application and Sclerotherapy in 1st and 2nd degree Hemorrhoids a comparative clinical study.  
Scientific Title of Study   A comparative clinical study on the efficacy of Apamarga Teekshna Kshara application and Sclerotherapy in Arsha w.s.r to 1 st and 2 nd degree Heammoroids - An open labeled, randomized, controlled clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  T Sushendra 
Designation  PhD Scholar , Professor 
Affiliation  J S Ayurved Mahavidyalaya and P D Ayurveda hospital. 
Address  OPD NO 136 Department of Shalyatantra J S Ayurved Mahavidyalaya and P D Ayurveda hospital. College road Nadiad

Kheda
GUJARAT
387001
India 
Phone  09900907644  
Fax    
Email  sushendra84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Manisha Kapadiya  
Designation  Assistant Professor  
Affiliation  J S Ayurved Mahavidyalaya and P D Patel Ayurveda hospital 
Address  OPD NO 136 Department of Shalyatantra J S Ayurved Mahavidyalaya and P D Patel Ayurveda hospital. College road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9974047713  
Fax    
Email  manisha.kapadiya15@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Manisha Kapadiya  
Designation  Assistant Professor  
Affiliation  J S Ayurved Mahavidyalaya and P D Patel Ayurveda hospital 
Address  OPD NO 136 Department of Shalyatantra J S Ayurved Mahavidyalaya and P D Patel Ayurveda hospital. College road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9974047713  
Fax    
Email  manisha.kapadiya15@gmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurved Pharmacy, J S Ayurved Mahavidhyalaya and P D Patel Ayurveda Hospital College road Nadiad Gujarat 387001 
 
Primary Sponsor  
Name  Dr T Sushendra 
Address  J S Ayurved Mahavidhyalaya and P D Patel Ayurveda Hospital College road Nadiad Gujarat  
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR T SUSHENDRA   J S Ayurved Mahavidhyalaya and P D Patel Ayurveda Hospital  OPD NO 136 Department of Shalyatantra J S Ayurved Mahavidhyalaya and P D Patel Ayurveda Hospital College road, Nadiad
Kheda
GUJARAT 		 09900907644

sushendra84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maganbhai Adenwala Mahagujarat University Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Sclerotherapy GROUP-B :( Sclerotherapy): A minimum of 30 patients will be treated by sclerotherapy. Methodology: In Lithotomy position, Under Local anesthesia the slit proctoscope will be inserted and confirm the position of Hemorrhoids. The Sclerosant solution (Inj 3 % Polidocanol) will be injected through a very fine needle directly into the submucosa of hemorrhoids. This procedure will be performed under the supervision of General Surgeon. After the procedure patient observation will be done on 1st, 7th
2Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta Samhitha Chikitsa sthana 6th chapter sloka no 4, Procedure details: GROUP-A: (Apamarga Teekshna Kshara Application): Minimum 30 patients will be treated by Apamarga Teekshna Kshara application. Methodology: In Lithotomy position, Under Local anesthesia with 2% xylocaine and adrenaline solution, the slit proctoscope will be inserted and confirm the position of Hemorrhoids. The hemorrhoidal mass will be cleaned with normal saline and the Apamarga Theesksna Kshara will be applied on Hemorrhoidal mass. After 100 matra kala when the hemorrhoidal mass turns into Pakw)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age- 18 to 60 years.
2.Patients with 1st and 2nd degree internal Hemorrhoids having bleeding,pain and itching in anal region.
2.1 Mrdu, Prasruta, Avagadha, Uchritani (soft, deep seated and elevated Hemorrhoids).
3. Controlled case of HTN, DM and Cardiac disorders.
 
 
ExclusionCriteria 
Details  1. Age less than 18 years and more than 60 years
2. 3rd and 4th degree hemorrhoids
3. Rectal prolapse
4. Patients of Acute and Chronic anal fissure
5. Hemorrhoids associated with Fissure and fistula-in-Ano
6. Uncontrolled Hypertension, Diabetes Mellitus, Cardiac disorders
7. Ano rectal Malignancy.
8. Pregnant women
9. Hepatitis B, Tuberculosis, HIV & VDRL positive cases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in synptomatology of 1st and 2nd degree internal heamorroids given below-
1.Pain during defecation
2. Bleeding during defecation.
3. Itching around the perianal region.
 		 Before starting the procedure.
After the procedure at 1st ,7th,14th ,21st and 28th day.  
 
Secondary Outcome  
Outcome  TimePoints 
1.VAS
2.Size of Hemorrhoid mass
 		 Before starting the procedure.
After the procedure at 1st ,7th,14th ,21st & 28th day.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/03/2024 
Date of Study Completion (India) 18/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Methodology:

·         Study design: Randomized control clinical study.

·         Grouping: Patients shall be allotted into two groups by computer generated randomization chart.

 Pre- operative procedures in Group A and Group B:

Ø  Enema will be given in the before surgery.

Ø  Written informed consent will be taken before surgery.

Ø  Lignocaine 2 % sensitivity test will be done (0.1ml intradermal).

Ø  Inj. Tetanus Toxoid 0.5 ml intramuscular will be given to each patient.

Ø  Local part will be prepared (local shaving) before operation.

Operative procedure:

GROUP-A: (Apamarga Teekshna Kshara Application): Minimum 30 patients will be treated by Apamarga Teekshna Kshara application.

Methodology: In Lithotomy position, Under Local anesthesia with 2% xylocaine and adrenaline solution, the slit proctoscope will be inserted and confirm the position of Hemorrhoids. The hemorrhoidal mass will be cleaned with normal saline and the Apamarga Theesksna Kshara will be applied on Hemorrhoidal mass. After 100 matra kala when the hemorrhoidal mass turns into Pakwa Jambu Phala Varna. The Kshara will be washed out with Citrus juice.

 GROUP-B :( Sclerotherapy): A minimum of 30 patients will be treated by sclerotherapy.

 Methodology: In Lithotomy position, Under Local anesthesia the slit proctoscope will be inserted and confirm the position of Hemorrhoids. The Sclerosant solution (Inj 3 % Polidocanol) will be injected through a very fine needle directly into the submucosa of hemorrhoids. This procedure will be performed under the supervision of General Surgeon of  Mahagujarat Hospital, Nadiad, Gujarat.

Post operative: General Management in both the groups: (for 15 days)

·         Vital data like TPR, BP will be monitored and recorded.

·         Hot sitz bath was advised with 4 L of Panchavalkala Kwatha twice a day.

·         Triphala guggulu 500 mg will be given twice a day after meal with luke warm water.

·         Eranda Bhrushta Haritaki Churna 5 g will be given at night with luke warm water.

·         10 ml Jatyadi Taila Matra Basti will be given in the morning.

·         Antibiotic (Tablet amoxicillin 500mg + potassium clavulanate 125mg 1 tablet after food twice a day) will be given in the initial 5 days.

· Dietary regimen

The patients will be directed to follow dietary restrictions according to the etiology of hemorrhoids. Apart from this, all the patients will be restrained from strong and spicy foods, coffee, tea, increased quantity of milk and milk products, condiments, and other food items. And advised to take a regular and proper fibrous diet with adequate quantity of water.

 

Observation and Follow-up: Patient observation will be done on 1st, 7th, 14th, 21st and 28th day of treatment and follow up after 1 months of treatment.  
Close