| 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] |
|
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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 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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: - |
|
|
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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 |
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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. |