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CTRI Number  CTRI/2023/08/057153 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 08/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Non surgical treatment for hemorrhoid. 
Scientific Title of Study   A comparative study on efficacy of Durnamhara Lepa and Shigrumoolaadi Lepa in Arsha Roga 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Baljit  
Designation  PG Scholar 
Affiliation  Shri Krishna Govt Ayurvedic College and Hospital 
Address  Room no. 102 PG Depatment of Shalya Tantra Shri Krishna Govt Ayurvrdic College and Hospital Umri Road Sec 8, Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  8053868118  
Fax    
Email  baljeet.mahala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajender Singh 
Designation  Associate Professor 
Affiliation  Shri Krishna Govt Ayurvedic College and Hospital 
Address  Room no. 102 PG Depatment of Shalya Tantra Shri Krishna Govt Ayurvrdic College and Hospital Umri Road Sec 8, Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  8708866794  
Fax    
Email  drrajendersingh1346@gmail.com  
 
Details of Contact Person
Public Query  
Name  Baljit  
Designation  PG Scholar 
Affiliation  Shri Krishna Govt Ayurvedic College and Hospital 
Address  Room no. 102 PG Depatment of Shalya Tantra Shri Krishna Govt Ayurvrdic College and Hospital Umri Road Sec 8, Kurukshetra


HARYANA
136118
India 
Phone  8053868118  
Fax    
Email  baljeet.mahala@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Govt Ayurvedic College and Hospital Kurukshetra , Haryana 136118 
 
Primary Sponsor  
Name  Shri Krishna Govt Ayurvedic College and Hospital 
Address  Shri Krishna Govt Ayurvedic College umri road sec 8 Kurukshetra Haryana 136118 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Baljit  Shri Krishna Govt Ayurvedic College and Hospital  Room no.14 Shalya Vibhag Shri Krishna Govt Ayurvedic College and Hospital Umri Road Sec 8 Kurukshetra 136118
Kurukshetra
HARYANA 		 8053868118

baljeet.mahala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Durnamhara Lepa, Reference: Rasa Ratna Samuchhaya, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shigrumooladi lepa, Reference: Rasa Ratan Samuchhaya, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with age group of 16-65 yrs.
2.Patients with 2nd and 3rd degree internal piles.
3.Patients who are willing to give consent for treatment. 
 
ExclusionCriteria 
Details  1. Patients with age group of less than 16yrs and more than 65 yrs.
2. Pregnant females.
3. Patients with malignancy.
4. Patients with rectal prolapsed.
5. Patients with 1st and 4th degree hemorrhoides.
6. Patients having hemorrhoides associated with fissure and fistula in ano.
7. Patients having hepatitis B , TB, HIV positive cases.
8. Acute and Chronic anal fissure.
9.Uncontrolled hypertension and DM. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the comparative efficacy of Durnamahara Lepa & Shigrumooladi Lepa in Arsha Roga.  Duration of the treatment- It will be given for 14 days.
Route of administration- Local application.
Dose- according to pile mass.
Follow up- it will be done after 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the role of Durnamahara Lepa in management of Arsha Roga.
2. To assess the role of Shigrumooladi Lepa in management of Arsha roga. 		 Duration of the treatment- It will be given for 14 days.
Route of administration- Local application.
Dose- according to pile mass.
Follow up- it will be done after 7 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/ Phase 3 
Date of First Enrollment (India)   01/09/2023 
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="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 (Haemorrhoids) is a clinical condition involving ano- rectal region in which structural

derangement take place. During process of pathogenesis, the DoÅŸhas are vitiated due to indulgence

in etiological factors by the person that in turn leads to Agnimandya that further hampers the

functions of Apana vayu. These vitiated Doshas get localized in the Mamsa and Meda of guda pradesha, which result into appearance of Mamsa prarohas or Arsha. Acharya Sushruta placed this disorder in the “Ashta Mahagada”. A lepa is the initial treatment which is common to all inflammatory swellings. A lepa not only relives pain and swellings, it also alleviates dosha, causes shodhana and helps to in healing process. In my study there is two lepa i.e. Durnamhara lepa and Shigrumooladi lepa. Durnamhara lepa contains kadvi tumbi(Lagenaria Vulgaris) and guda(Jaggery). Whereas Shigrumooladi lepa contains Shigru(Moringa Olifera) and Arka(Calotropis gigantea). These drugs possess Katu and Tikata Rasa, Katu Vipaka, Ushana Virya, which may acts as Chedana on Arsha roga. Total 60 patients will be randomly selected for the study, with ages ranging

from 16 years to 65 years, irrespective of gender, religion, occupation, socio- economic status etc. Duration of Treatment : The duration of treatment for Group-1 and Group-2 patients is taken for 14 days. The therapeutic effects will be analyzed by using the subjective parameters viz. pain and itching  and objective paramaters viz, number &size of pile mass, BPR (bleeding per rectum), prolapse etc. Follow-up:-Patients will be called, once after a week i.e. on 21st day. Then two times on monthly  basis i.e. on 51th day and 81th day; in 3 sittings.

 
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