CTRI Number |
CTRI/2020/09/028052 [Registered on: 25/09/2020] Trial Registered Prospectively |
Last Modified On: |
17/09/2020 |
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
|
Study of effect of Kalingadi Vati in piles |
Scientific Title of Study
|
A randomised clinical study for efficacy of Kalingadi Vati in the management of Arsha with special reference to 1st and 2nd degree Haemorrhoids |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepali Ajitrao Kolnure |
Designation |
PG student |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Address |
OPD no 6 Shalyatantra Department
Nashik MAHARASHTRA 422003 India |
Phone |
9284202284 |
Fax |
|
Email |
kdeepalida@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vinay Sonambekar |
Designation |
Professor and Guide |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Address |
OPD No 6 Shalya Tantra Department
Nashik MAHARASHTRA 422003 India |
Phone |
9822624890 |
Fax |
|
Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vinay Sonambekar |
Designation |
Professor and Guide |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Address |
OPD No 6 Shalya Tantra Department
MAHARASHTRA 422003 India |
Phone |
9822624890 |
Fax |
|
Email |
sonambekar.chinmay@gmail.com |
|
Source of Monetary or Material Support
|
Dr Deepali Ajitrao Kolnure
Ayurved Seva Sangh Ayurved Mahavidyala Nashik
Ganeshwadi Panchavati Nashik |
|
Primary Sponsor
|
Name |
Ayurved Mahavidyalaya Nashik |
Address |
Ganeshwadi Panchavati Nashik |
Type of Sponsor |
Other [State Govt Grant in aid Institute] |
|
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 Deepali Ajitrao Kolnure |
Arogyashala Rugnalaya Nashik |
OPD No 6 Shalya Tantra Department Nashik MAHARASHTRA |
9284202284
kdeepalida@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ayurved Seva Sangh Ayurved Mahavidyalaya Instutitional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Kalingadi Vati |
500 mg twice daily before meal with lukewarm water for 30 days |
Comparator Agent |
Pilex tabelt |
1gm twice daily after meal with lukewarm water for 30 days |
|
Inclusion Criteria
|
Age From |
17.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patient having clinical features of Arsha
Agnimandya.
Saraktmalpravritti.
Malavshthambha.
Gudshool.
Gudkandu
|
|
ExclusionCriteria |
Details |
Diagnosed case of Carcinoma of rectum large intestine rectal polyps prolapse of rectum fistula in ano crohns disease fissure in ano
Pregnant women and lactating mother
Patients having systemic diseases like liver cirrhosis portal hypertension
Severe anaemic patient
Bleeding disorders like haemophilia and purpura
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Decrease in bleeding tendancy
Relief in anorectal pain and inflammation
|
30 days
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Relief in constipation
Relief in anorectal itching
Improvement in digestion |
30 days |
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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)
|
28/09/2020 |
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
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
According to Ayurveda apathya aahar,
vihar leads to vatadi dosha dushti at the guda vali (anal region), pradhan
dhamani (venous supply),mansadhara kala and vitiates twaka,mansa,rakta,meda resulting
in annavaha strotas dushti,agnimandya and arsha According to
modern science, haemorrhoid is engorgement of haemorrhoidal venous plexus
characterized by bleeding per rectum,constipation,pain,prolapseand discharge.
A growing inclination for fast food, faulty food habbits, spicy junk foods,
aerated cold drinks, low intake of fiber rich diet.Stressfulprofessions,busy
lifestyle, constipation, insomnia that’s all affect the health of the body.
Because of all these things constipation occurs. Long duration of constipation
and prolonged straininglead to engorgement of veins in anal canal and gives
birth to haemorrhoids.
In modern
science, haemorrhoids have very limited options for treatment which are mostly
different surgical modalities like Lord’s anal dilatation, Cryosurgery, laser
haemorrhoidectomy, injection sclerotherapy, rubber band ligation
etc. But arsha disease is mainly related to sedentary lifestyle and hampered
digestive system.So even after the surgical treatment and modern conservative
treatment there is probability of recurrenece andpostoperativepain is very
troublesome. Anal stenosis and incontinence are deadful complaints. The cost of
surgery is also relatively highso patients are not readily willing for surgery.
According to
Sushrut Samhita and Vagbhata Samhita, there are four
treatment modalities of arsha i.e. bhaishajchikitsa (internal medicine), kshara
karma (chemical cauterization), Agnikarma (thermal cauterization) and shastra
karma (surgicaltechnique). Agnimandya is the main etiological factor of arsha.
One important effective formulation is kalingadi vati explained in
Ashtangahrudaya. The ingredients of this vati are
Kalinga,Langali,Pippali,Apamarga,Bhunimba etc. The properties of these dravyas
leads to Agnideepana, Arshoghna, Pachan, Shothahar, Shoolghna and Sthambhan.
Hence it can break down the samprapti of arsha disease. So we have decided to
study the efficacy of kalingadivati in the management of arsha which is very
cost effective and easily available. Ayurveda Samhita provide
us the opportunity to treat arsha with cost effective medication instead of
surgical procedure. Raktastrava and agnimandya is the main complaint of the
patient in the arsha disease. According to ayurvedic Samhita there are two
types of arsha that is Stravi and Astravi. Kalingadivati seems to
be an ideal formulation which can cause Agnideepana also Raktstambhan.Tilldate
no study has been conducted on kalingadivati.Therefore it was decided to take
up this study.
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