| CTRI Number |
CTRI/2025/06/089803 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
AYURVEDIC MANAGEMENT IN GUDGATVIKAR (MULVYADH)(Arsha-PILES) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Dugdhikadi Vati In Arsha W.S.R.T.Internal Haemorrhoids |
| 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 ANJALI RAJENDRA NAWALE |
| Designation |
PG Scholar Shalyatantra Dept. |
| Affiliation |
ASS, Ayurvedic Mahavidyala Nashik |
| Address |
Shalyatantra OPD No.6 AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
Shalyatantra OPD No.6 AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
Nashik
MAHARASHTRA
422003
India |
| Phone |
7057763148 |
| Fax |
|
| Email |
anjalinawale7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Sonambekar |
| Designation |
MS Shalyatantra |
| Affiliation |
ASS, Ayurvedic Mahavidyala Nashik |
| Address |
AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANJALI RAJENDRA NAWALE |
| Designation |
PG Scholar Shalyatantra Dept. |
| Affiliation |
ASS, Ayurvedic Mahavidyala Nashik |
| Address |
Shalyatantra OPD No.6 AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
Shalyatantra OPD No.6 AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
Nashik
MAHARASHTRA
422003
India |
| Phone |
7057763148 |
| Fax |
|
| Email |
anjalinawale7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra OPD No.6 AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI,NASHIK 422003,Maharashtra ,India |
|
|
Primary Sponsor
|
| Name |
AROGYASHALA RUGNALAYA GANESHWADIPANCHVATI NASHIK |
| Address |
AROGYASHALA RUGNALAYA GANESHWADI NASHIK |
| Type of Sponsor |
Other [self] |
|
|
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 Anjali Rajendra Nawale |
Arogyashala Rugnalaya |
Shalyatantra OPD No.6 AROGYASHALA RUGNALAYA GANESHWADI,PANCHVATI NASHIK
Nashik
MAHARASHTRA |
7057763148
anjalinawale7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dugdhikadivati, Reference: Sartha Vagbhat, Vagbhatkrut ashtang hrudaya evum Marathi bhashantar by Dr.Ganesh Krushna Garde Chaukhamba surbharati prakashan published in 2018, Nidan Sthan Chapter 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pylonash, Reference: ushrut Samhita of Sushruta edited with ayurved tatva sandipika by kaviraj Ambikadas Shastri Nidansthana Dvitiya Adhyaya ,Fourth phrase , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient Dignosed with I & II degree of Internal
Haemorrhoids of both Sexes.
Patient having age group between 20-70 years both male and female.
Patients having following Clinical features of Arsha a)Agnimandya
b)Saraktamalpravruti
c)Gudashool
d)Gudakandu
e)Malavshtambha
Patients willing to participate with informed written consent. |
|
| ExclusionCriteria |
| Details |
Patients below age 20 years & above the age of 70 years
Diagnosed case of Carcinoma of rectum,large intenstine,prolpase of rectum, rectal
polyps,fissure in ano,fistula in ano,crohn’s disease.
Pregnant women and lactating mother
Severe anaemic patient .
Patients having systemic disorders ilke portal hypertension,liver cirrhosis.
Patient having immunocompromised disorders.
Bledding disorders like haemophillia and purpura.
|
|
|
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 |
| Does Dugdhikadi Vati is effective in Reducing signs and symptoms of Arsha? in 4 weeks in 80 patient |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Does Dugdhikadi Vati is helps to stop Bleeding in the treatment of Arsha ?
2)Does Dugdhikadi Vati is helps to mala-anulomana effect in the treatment of Arsha ?
|
4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/07/2025 |
| 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
|
The Formulation of Dugdhikadi Vati is cost effective,easily available and may gives
symptomatic relief and prevent surgical intervention. The main complaint of arsha is
Raktastrava and agnimandya .As per ayurveda samhinta, arsha is of two types Stravi
Arsha [Rakta Arsh, Shuska Arsha .The Dugdhikadi Vati seems to be an ideal formulaton
which can cause Raktasthambhana ,shulaharana, Agnideepana and anti inflammatory
property. Hence the topic is choosen for the Study |