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CTRI Number  CTRI/2025/07/092101 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effects gunjadi varti and ghoshaphala varti in the treatment of bleeding piles.(Abhyantar guda arsha) 
Scientific Title of Study   A clinical control study of gunjadi varti and ghoshaphala varti in the management of abhyantar guda arsha (2nd degree haemorrhoid) 
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 Mayuri Ramchandra Makode  
Designation  Post graduate scholar 
Affiliation  Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal.Sangamner, Dist.Ahmadnagar 
Address  OPD No.5 Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal.Sangamner, Dist.Ahmadnagar

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  8482991883  
Fax    
Email  mayurimakode97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishal Tamhane 
Designation  Reader 
Affiliation  Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal.Sangamner, Dist.Ahmadnagar 
Address  OPD No.5 Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal.Sangamner, Dist.Ahmadnagar.

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9764139607  
Fax    
Email  vtamhane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal Tamhane 
Designation  Reader 
Affiliation  Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal.Sangamner, Dist.Ahmadnagar 
Address  OPD No.5 Shalya Tantra Department, Ashvin Rural Ayurved College and Hospital, Sadhvi Preetisudhaji Maharaj Nagar, Manchi Hill, Ashvi Bk, Tal.Sangamner, Dist.Ahmadnagar

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9764139607  
Fax    
Email  vtamhane@gmail.com  
 
Source of Monetary or Material Support  
Ashvin rural ayurved college and hospital, sadhvi preetisudhaji maharaj nagar, manchi hill, ashvi bk, tal.sangamner, dist.ahmadnagar 
 
Primary Sponsor  
Name  Dr Mayuri Ramchandra Makode 
Address  Ashvin rural ayurved college and hospital, sadhvi preetisudhaji maharaj nagar, manchi hill, ashvi bk, tal.sangamner, dist.ahmadnagar 
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 Mayuri Ramchandra Makode  Ashvin rural ayurveda college and hospital   Opd no.5,shalya tantra department, ashvin rural ayurved college and hospital sadhvi preetisudhaji maharaj nagar, manchi hill, ashvin bk, tal.sangamner, dist.ahmadnagar
Ahmadnagar
MAHARASHTRA 
8482991883

mayurimakode97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Ashvin Rural Ayurved College and Hospital Manchi hill, Ashvi Bk., Tal.Sangmaner, Dist.Ahmadnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ghoshaphala Varti, Reference: . Acharya Vishwanath Dwiwedi, Raj Nighantu, Chaukhamba publication, 4th reprint 2006, page no- 37., Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Gunjadi Varti, Reference: Kaviraj shri Ambikadattashastri Ayurvedacharya, Bhaishajyaratnawali, chaukhamba publication, page no- 297, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient having 2nd degree haemorrhoids.
2.Selection of patient will be done irrespective of sex ,religion and socioeconomic class. 
 
ExclusionCriteria 
Details  1)Patient having 3rd & 4th degree haemorrhoids.
2)Patient having CA Rectum & anal canal.
3)Pregnancy.
4)Patient having DM, HTN, HIV, HBsAG, Tuberculosis or any other systemic
disorder. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Gunjadi Varti and Ghoshaphala Varti in reducing key symptoms of abhyantar guda arsha (2nd degree haemorrhoids) over a period of 28 days, assessed both subjectively and objectively.
Subjective parameters:
Vedana(pain)
Toda(pricking pain)
Kandu(itching)
Malavbaddhata(constipation)
Colour of pile mass

Objective criteria:
Number of arshankur(haemorrhoids)
Bleeding.
 
Weekly upto 28 days  
 
Secondary Outcome  
Outcome  TimePoints 
Overall symptom relief grading
Excellent greater than 75 percent relief
Marked 41 to 75 percent
Moderate 25 to 50 percent
Mild less than 25 percent
Safety & tolerability
Any adverse effects or withdrawal due to side effects
Comparative effectiveness to determine which formulation is more effective clinically & objectively  
Weekly upto 28 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   16/08/2025 
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="6"
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   To compare the efficacy of Gunjadi varti and Ghoshaphala varti in the management of abhyantar guda arsha (2nd degree haemorrhoid)
It has become notorious to manage Arsha through surgical procedure due to post-operative pain associated with many more complications. Also, surgery is not possible in many cases like extremes of age, surgically unfit persons, pregnancy. Both modern and ancient Indian system of medicine mentioned conservative (bheshaja) treatment for foremost Consideration. Ayurveda advocated equal importance to sthanik chikitsa along with bheshaja chikitsa in the form of lepa (creams/ointments), avagahan (fomentation), parishek (sprinkling), raktamokshan (bloodletting), abhyanga (local massage), Dhupan (Fumigation). Other than many oral medications for symptomatic treatment in Arsha, patients mostly need and ask medicine for local application for instant relief, mental satisfaction and avoidance of oral preparations due to fear of gastric troubles & bad taste of some medicines especially herbal preparations. Herbal and contemporary ointments for local application available in the pharmacy for the management of haemorrhoids have plastic applicators which while application sometimes make trauma/hurt inside the anal canal. So, when medicine has to be applied internally in internal hemorrhoids Gudavarti or rectal suppository must be a better option to avoid trauma and also it is easy for the patient to administer it by self at home. Varti Kalpana has been mentioned in almost all the Ayurvedic treatises viz. Charaka samhita, Sushruta Samhita, Ashtanga hridaya, Rasarathna samucchaya, Bhaishajya ratnavali, and Chakradatta. Bhaishajya ratnavali widely contributes different Guda Vartis in different diseases. It has been used to attain quick relief from conditions like Udavarta, Mutrkriccha, Baddha Koshta, Shula, Basti vyapad, Arsha. It causes vayu anulomana which results in the elimination of mala and mootra along with the removal of sanchitha rakta sleshma pooya dosas. Contemporary Suppositories are the modified form of ancient Varties. Rectal suppositories are used to produce local action at the site of application but many of them are used to produce systemic actions. Presently most common rectal suppository used in the management of hemorrhoidal disease is corticosteroid based (eg. hydrocortisone) along with anesthetic (eg. lidocaine), emollient (eg. allantoin), protectant & astringent (eg. zinc oxide). Medicinal herbs have numerous bioactive molecules & could be traced for their therapeutic potentials and converted into various dosage forms for convenience in treatment. Recent advances hence could be utilized for moulding Varti into suppository and enhancing the scope of therapeutic dosage forms. 
 Conclusion:  Gudavarti causes vatanuloman & removes sanchitha rudira, stambha, shoola, kandu, shwayathu in arshas. It treats arshas from its roots (Arsh samoola nivratheye). Hence, it could be used as a safe, simple & efficacious first line treatment along with oral medications in the Management of arsha.
 
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