| CTRI Number |
CTRI/2024/06/069199 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Siddha formulation Gowri Chinthamani Chendooram for Moolam [Haemorrhoids] |
|
Scientific Title of Study
|
An Interventional Study to evaluate the effectiveness of Siddha formulation Gowri Chinthamani Chendooram along with Siddha line of treatment Seeraga thylam oilbath and Moolakudara thylam laxative in the treatment of Moolam (Haemorrhoids) among Out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennnai-47 |
| 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 Abirami S |
| Designation |
Pg scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha,Tambaram Sanatorium
Chennai.
Chennai TAMIL NADU 600047 India |
| Phone |
9597350346 |
| Fax |
|
| Email |
abiramisammu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha,Tambaram Sanatorium.
Chennai TAMIL NADU 600047 India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha,Tambaram Sanatorium.
Chennai TAMIL NADU 600047 India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
National Institute of Siddha, Tambaram Sanatorium, Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Siddha |
| Address |
Room no 7/8 ,Department of maruthuvam,National Institute of Siddha ,Tambaram sanatorium ,Chennai-47. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abirami S |
Ayothidoss Pandithar Hospital |
Room no7/8,Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai-47. Chennai TAMIL NADU |
9597350346
abiramisammu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gowri chinthamani chendooram |
200 mg of Gowri Chinthamani Chendooram along with Adjuvant 1.375 g (Kattukarunaikilangu podi+
kadukkai podi +sukku podi + thippili podi) with honey Bd, after food for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Degree I – II Haemorrhoids
2. Participants with Haemorrhoid Symptom Scoring (HSS) ≥ 5
3. Participants willing to undergo proctoscopic examination
4. Participants willing to give blood samples for the investigations required
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactation.
2.Fistula in Ano
3.Fissure in Ano
4.External haemorrhoids
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of Haemorrhoid Symptom Scoring (HSS) after treatment.
Reduction in the size of the Pile mass in Proctoscopic examination after treatment.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
25/06/2024 |
| 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="0" 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
|
BACKGROUND: Siddha system of medicine is one of the traditional systems of
medicine in India. The uniqueness of siddha system is evident by its continuous
service to the mankind in combating diseases and also in maintaining its
physical, mental and moral health. The diagnosis of disease in siddha system of
medicine relies on eight diagnostic tools called Ennvagai Thervu such as Naadi,
Sparisam, Naa, Niram, Mozhi, Vizhi, Malam, Moothiram which are evaluated in
terms of three humors. Saint Agasthiyar identified 4448 diseases and one among
them is Eruvai Mulai noi. Any derangements in humors results in development of
diseases. Yugi mentioned the disease Moolam and its types in Yugi Vaithiya
Chinthamani. This disease is mainly due to aggravated vatham and pitha humors.
In Moola noi, deranged Vatha humor triggers keelvai kanal (abana vaayu) which
in turn stimulates pitham humor resulting in Moolam with the symptoms of
constipation, bleeding during defecation, pain in umbilical region, pallor of
the body, headache, giddiness are developed. As per Siddha, Siddhars notify
Moolatharam is a seat of Kundalini Sakthi (Energy point). Any irregular
practice of yoga, food and lifestyle modifications may disturb the moolatharam
and results in disease called Moolam. Haemorrhoids are a very common anorectal
condition and is formed by a dilatation of veins in the external and internal
haemorrhoidal plexuses. Clinically there are two types of Haemorrhoids
viz. Internal Haemorrhoids and External Haemorrhoids. Based upon the protrusion
of mass, it’s subdivided into 4 grades. Etiological factors include
Constipation, a low fiber diet, a sedentary lifestyle, a high Body Mass Index,
pregnancy, hereditary and are often assumed to increase the risk of
haemorrhoidal disease (HD). The common presenting symptoms of haemorrhoids are
the painless rectal bleeding, pruritus, fecal soilage, perianal irritation, or
mucus discharge .Usual treatments provided for Haemorrhoids are conservative
management includes stool softeners, bulking agents for stage 1and 2. Conditions
Refractory to conservative management or stage 3 and 4 Hemorrhoids will be
treated surgically . The recurrence rate after stapled hemorrhoidopexy and
conventional hemorrhoidectomy 0 to 26 % and 0 to 10.8%, respectively;
reoperation rate was 16.7 % after stapled hemorrhoidopexy. In Siddha system,
the line of treatment for Moola noi has been designed as internal medicines,
external therapies such as Kattu, Pattru, Poochu, Pugai, Kalimbu, Neer and Yoga
maruthuvam. By following the siddha line of treatment for moolam along with
proper dietary advise, the recurrence rate of the disease and the need for
expensive surgeries can be mitigated. OBJECTIVE: To evaluate the
effectiveness of siddha formulation GOWRI CHINTHAMANI CHENDOORAM in the treatment of MOOLAM ( FIRST AND SECOND DEGREE
HAEMORRHOIDS) among Haemorrhoids patients through proctoscopy and
Haemorrhoid symptom scoring (HSS) before and after treatment. STUDY DESIGN: This is an
interventional study of Non randomized sampling which will be carried out
for 6 months in patients with haemorrhoids reporting at OPD of Ayothidoss
Pandithar Hospital, National Institute of Siddha, Chennai – 600 047 with 20
patients as sample size. Patients with Age ≥ 18 years and ≤ 60 years of Both
sex, and Participants with First and second degree
Haemorrhoids, Participants with
Haemorrhoid Symptom Scoring (HSS) ≥ 5, Participants willing to undergo
proctoscopic examination, Participants willing to give blood samples for the
investigations required will be included in this study. Patients with fissure
in ano, fistula in ano, external haemorrhoids and pregnant and lactating women
will be excluded from the study. OUTCOME OF STUDY
Improvement of Haemorrhoid Symptom Scoring (HSS) after
treatment.
Reduction in the size of the Pile mass in Proctoscopic
examination after treatment RESULTS AND DISCUSSION: The results will be statistically analysed
and reported. KEYWORDS: moolam, anorectal diseases, Gowri chinthamani
chendooram.
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