| CTRI Number |
CTRI/2024/04/066450 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
the Oral Medications with the Panchakarma is treatment is given for Obesity induced Fibroid Uterus |
|
Scientific Title of Study
|
A DOUBLE ARM CLINICAL STUDY ON OBESITY INDUCED FIBROID UTERUS THROUGH LEKHANA BASTI IN YOGA BASTI SCHEDULE FOLLOWED BY SHAMANOUSHADI |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaithra T M |
| Designation |
MD(Student) |
| Affiliation |
Ayurveda mahavidyalaya college and hospital |
| Address |
Ayurveda mahavidyalaya college
Heggeri, old hubli,
Hubli,
Department of Kayachikitsa
OPD NO 5,
Ground floor
Dharwad
KARNATAKA
580030
India |
| Phone |
09590011998 |
| Fax |
|
| Email |
chaithrachaitu232@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pramod Katti |
| Designation |
Professor |
| Affiliation |
Ayurveda mahavidyalaya college and hospital |
| Address |
Ayurveda Mahavidyalaya college and hospital, heggeri, Old Hubli
Department of Kayachikitsa,
Opd NO 5
Ground floor
Dharwad
KARNATAKA
580030
India |
| Phone |
09886218596 |
| Fax |
|
| Email |
pramodayurveda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chaithra T M |
| Designation |
MD(Student) |
| Affiliation |
Ayurveda mahavidyalaya college and hospital |
| Address |
Ayurveda mahavidyalaya college
Heggeri, old hubli,
Hubli
Department of Kayachikitsa,
Opd NO 5
Ground floor
Dharwad
KARNATAKA
580030
India |
| Phone |
09590011998 |
| Fax |
|
| Email |
chaithrachaitu232@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya college and Hospital,
Heggeri
Old hubli, Dharwad
Pin code: 580030 |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 (India)
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Chaithra T M |
Ayurveda mahavidyalaya college and hospital,
Heggeri
Old hubli
Hubli
DHARWAD (DT)
Pin code : 580030 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chaithra T M |
Ayurveda mahavidyalaya college and hospital, |
Ayurveda mahavidyalaya college
Heggeri, old hubli,
Hubli,
Department of Kayachikitsa,
OPD NO 5
ground floor
Department of kayachikitsa
OPD 5
Ground floor
Dharwad
KARNATAKA |
09590011998
chaithrachaitu232@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda mahavidyalaya ethical committie |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: GRANTHIH, (2) ICD-10 Condition:N85||Other noninflammatory disorders ofuterus, except cervix. Ayurveda Condition: GRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayushnadi loha, Reference: Rasakamadhenu. purvarda, medonidana adhyaya, verse no 11-13, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Intuppu kanam choornam, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -It is the anubhuta yoga which contains the classical 5 drugs namely:
- Kanchanara
- Gomutra Haritaki
- Guggulu
- Swarna Makshika Bhasma
- Shilajatu | | 3 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sharangadhara, purva khanda,4/10, Procedure details: Sthanika abhyanga with murchitha tila taila
Anuvasana basti with hingu triguna taila
lekhana basti with triphala kwatha)
(1) Medicine Name: Hingu triguna taila, Reference: Astanga hridaya,chikitsa sthana, 14/39, Route: Rectal, Dosage Form: Taila, Dose: 48(ml), Frequency: od, Duration: 8 Days | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: intuppu kanam choornam, Reference: sahasrayoga, choorna prakarana, 14/39, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: nothing |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosed cases of Fibroid Uterus on the basis of Ultrasonography of the Abdomen and Pelvis.
2. Subjects(participants) who are having the size of Fibroid up to 5 cm.
3. Patients having a B.M.I. 25 - 30 (moderate obesity).
4. Female patient with age limitation of 25 to 55.
5. Patients having clinical features of Fibroid Uterus.
|
|
| ExclusionCriteria |
| Details |
1. Subjects(participants) who do not fulfill the inclusion criteria will be excluded from the study.
2. Disorders of reproductive tract such as Congenital anomalies, Tuberculosis, Carcinoma.
3. Subjects(participants) suffering with any Chronic illness, Uncontrolled metabolic disorders and systemic diseases.
4. Subjects(participants) suffering with HIV/VDRL/HBsAg/STD’s will be excluded.
5. Subjects(participants) who are having the Fibroid Size more than 5 cm.
6. Patients who are unfit for Basti.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight of the patient will be reduced |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the size of the fibroid uterus will be reduced |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
09/05/2024 |
| 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
|
In India, ‘The prevalence of Fibroids is reported to be 37.65 percent in Rural population and 24 percent in the Urban population’. The Fibroid Uterus has an estimated incidence of 20% - 40% in women during Reproductive years. According to the Global burden of disease study, 4.7 million people died prematurely in 2017 as a result of Obesity. The study conducted in 2005-2006 shows that prevalence of Obesity in Indian women has been elevated from 10.6% to 12.6%. The modern life style such as lack of physical activity, Sedentary life style and influence of high calorie diet that leads to Obesity. Obesity is a medical condition in which excess body fat is accumulated to an extent that it may manifest Diabetes, thyroid disorders, Atherosclerosis, Dyslipidemia, Hypertension and unwanted growth like neoplasia, Benign and Malignant tumors. The higher levels of circulating estrogen in obese women may lead to Endometrial disorders i.e., endometriosis, Fibroid Uterus, endometrial infections. Uterine Fibroids are also thought to be influenced by high concentration of Estrogens.The above mentioned Metabolic disorders are enumerated by acharyas under the heading of Santharponttha vikaras in Ayurveda. Abnormal and excessive accumulation of Kapha and medodhatu will results into manifestation of Sthoulya and other Santarpana vikaras like Prameha, Granthi, Apachi and Arbuda and Apatarpana chikitsa is the line of treatment for them. Accumulation of Udarasthameda dhatu in Sthoulya and formation of garbhashayagata Granthi are having common dosha, dhatu and sthana. Vitiated Kapha and Medodhatu gets deposited in garbhashaya layers like sub mucosal, intramural, sub serosal. Hence Samprapti and chikitsa of both the diseases are interlinked with each other. The involvement of Medoja Granthi, Dusta Kapha, Dusta Medas is due to the predominance of Pruthvi and Ap Mahabhutha at the site of Apana vayu and produces Sanghatmaka and granthi vikruti. The Treatment is aimed at administering Dipana, Pachana dravyas with the dominance of Vayu, Agni and Akasha mahabhutha. Therefore Karshana, Lekhana, Medohara chikitsa is to be implemented. |