| CTRI Number |
CTRI/2024/01/061205 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of ayurvedic application in the treatment of haemorrhoids |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare the effect of yavani churn and vidlavan with gudharitaki yog in the management of shushka arsha |
| 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 Sanjeevani S Bodhgire |
| Designation |
PG scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,pune |
| Address |
Department of shalyatantra ,Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8484070478 |
| Fax |
|
| Email |
bodhgiresanju1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDhanraj Bhagwan Gaikwad |
| Designation |
Associate professor, Shalyatantra department |
| Affiliation |
Tilak Ayurved Mahavidyalaya,pune |
| Address |
Department of shalyatantra ,Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
|
| Fax |
|
| Email |
Draj.gaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeevani S Bodhgire |
| Designation |
PG scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,pune |
| Address |
Department of shalyatantra ,Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8484070478 |
| Fax |
|
| Email |
bodhgiresanju1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth tarachand Ramnath Charitable Ayurvedic Hospital pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rasta peth Pune |
| Type of Sponsor |
Private medical 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 Sanjeevani Bodhgire |
Seth tarachand Ramnath ayurvedic hospital pune |
Tilak Ayurveda Mahavidyalaya Department of Shalyatantra OPD no.07 ground floor Rasta peth pune
Pune
MAHARASHTRA |
8484070478
bodhgiresanju1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudharitaki yog , Reference: Sharandhar samhira, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavani churn, Reference: Bhaishajyratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having textual symptom of pain in Shushka Arsh( haemorrhoids) will be taken as subject to
study
These criterions will be before treatment included in this study.
Haemorrhoid patient all position and 1" and 2 degree Internal haemorrhoids, External
Haemorrhoids
4 Patients of Shushkarsh having following signs and symptoms.
pain (vedana)
constipation (baddhkoshta)
Sadaha mala pravrutti
Gudkandu(Itching at anus)
Gudtoda
Trushna (Thirst)
Agnimandya(Loss of appetite)
Daurbalya(Weakness).
Alasya(Somnolence)
Aruchi(Anorexia)
Panduta (anaemia) |
|
| ExclusionCriteria |
| Details |
Patients suffering from arsh associated with following disease will be excluded
1. History of Hypertension
2. History of Immunocompromised, HBsAg, HIV patients
3. History of CA Rectum
4. History of Diabetes mellitus with metabolic disorders
5. 3 & 4 degree Haemorrhoids
6. Patient on anticoagulant |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Darshan pariksha - akruti,vrana Strav, vran tala, vran gandha,
Sparshan pariksha - Sparshatva, local temperature
Prashna pariksha - daha, Vedan,kandu |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrence of Akruti, vrana strava, vrana tala, vranagandha
Sparshatva, local temperature, daha, vedana,kandu |
After 28 day |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
17/01/2024 |
| 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="23"
Months="9"
Days="7" |
|
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
|
ShushkaArshas (External Haemorrhoids), is one among the and rectal disease which occursin Gudapradesh (Anus) a SadhyopranaharaMarma. Acharya Sushruta and Vagbhata describeit under AshtaMahagada. Shushka Arsha is a disease affecting mankind from thousands of years as it is traced in vedic period also. We are living in modern time where there is era of modernization and globalization. Due to modernization lifestyle changes very fastly. Negligence of proper diet and lifestyle habits ends in reducing power to digest (Agni) or making it abnormal called Mandagni. Due mandagni proper digestion of food not done it means inability to digest food material with proper pace and time leads to accumulation or stagnation of half digested food material (Ama). Westerndiet, spicy food, lack of time contributes enhancing factors of ShushkaArsha of vegadharan and mental stresses leads to many bowel disorders. All this factors contributes to in the development of ShushkaArsha. Arsh which are in dry nature and which manifest due to pathological vitiation of vata, kapha Or vatakapha are called shushkarsh therefore vataj, kaphaj and vatakaphaja types of arsh are called shushkarsh Or dry form of arsh. |