| CTRI Number |
CTRI/2024/08/072074 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda Treatment in management of infertility |
|
Scientific Title of Study
|
Efficacy of ayurveda treatment protocol in the management of anovulation W.S.R follicular study. An open label clinical trial |
| 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 Chesta |
| Designation |
PG Scholar |
| Affiliation |
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi |
| Address |
Department of Prasuti tantra and stree roga
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8618318503 |
| Fax |
|
| Email |
chestav5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girija Sanikop |
| Designation |
Professor and HOD |
| Affiliation |
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi |
| Address |
Department of Prasuti tantra and stree roga
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844362838 |
| Fax |
|
| Email |
gram.belgaum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girija Sanikop |
| Designation |
Professor and HOD |
| Affiliation |
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi |
| Address |
Department of Prasuti tantra and stree roga
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi
KARNATAKA
590003
India |
| Phone |
9844362838 |
| Fax |
|
| Email |
gram.belgaum@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BM Kankanadwadi Ayurveda Mahavidyalaya & KLE Ayurveda Hospital Shahapur Belagavi 590003 karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Chesta |
| Address |
Department of Prasuti tantra and stree roga
KAHER shri BMK Ayurveda mahavidalaya Shahapur Belagavi |
| 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 Chesta |
KAHER shri BMK Ayurveda Mahavidalaya and Hospital |
Room number 23
Department of Prasuti tantra and stree roga
Belgaum
KARNATAKA |
8618318503
chestav5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee for research on human subject |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka Samhita, Siddhisthana (9/63) Hindi commentary by Prof. Ravi Dutt Tripathi and Acharya Vidydhar Shukla, Part 2, Chaukambha Sanskrit Prakashan, Delhi -2013., Procedure details: ON 6th day of mensturation -Matra Basti with Dhanwantari taila 7th day Dashmoola niruha basti followed by Dhanwantari taila uttar basti 8th day Matra Basti with Dhanwantari taila 9th day Dashmoola niruha basti followed by Dhanwantari taila uttar basti 10th day Matra Basti with Dhanwantari taila 11th day Dashmoola niruha basti followed by Dhanwantari taila uttar basti 12th day Matra basti with Dhanwantri taila for 2 months Five milliliters of Uttar Basti for six days, in one cycle (after cessation of menstruation), will be given with an interval of three days in between for two consecutive cycles, with the consent of the patient. The patient will be admitted for Uttar Basti, a day after cessation of menstruation. Snehana (oleation) of dashmoola taila on the lower abdomen, back, and lower limbs followed by Nadi Sveda with water steam on the lower abdomen and back will be given to patients before each Uttar Basti. The procedure will be carried out in the operation theater. The oil and instruments will be autoclaved. The patient will be placed on the operation table in a dorsal lithotomy position. The private part (already shaved) will be cleaned with antiseptic solution. The vagina and cervix will be visualized with the help of the Sim’s speculum and an anterior vaginal wall retractor. The anterior lip of the cervix will be held with the help of the Allis’ forceps. Uterine sounding will be done and then Uttar Basti cannula, already attached with 5 mL syringe filled with Dhanwantari taila will passed into the uterine cavity after making a head low position. The drug will be pushed above the level of the internal os with constant force, The patient will be sent to bed and the bed will be kept with head low for two hours. The lower abdomen will be fomented with hot water bag. Patients will be asked to avoid very spicy food during treatment. Coitus will be prohibited during the course of Uttar Basti )
(1) Medicine Name: Hinguvachadi vati , Reference: Astanga hrdaya,uthara sthana :Chapter 14th ,sloka 31-33, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
A Married Women of age group of 20 - 35 years.
B Women who are diagnosed with anovulatory cycles.
C Known case of PCOS with anovulatory cycles
D Women who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
A A Known case of chronic systemic disorders (diabetes mellitus, hypertension, tuberculosis) and endocrinal disorders.
B H/o Any organic lesions of reproductive tract like tuberculosis, carcinoma and congenital deformities, or any other pelvic pathology.
C Known case of ovarian cyst.
D Patients suffering from adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, Cushing’s syndrome, cardiac diseases will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Follicular study |
Baseline
2nd cycle
3rd cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Menstrual abnormalities (oligomenorrhea polymenorrhea
hypomennorhea) |
baseline
1st cycle
2nd cycle
3rd cycle |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="2"
Months="0"
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
|
Anovulation is when the ovaries do not release a secondary oocyte during a menstrual
cycle. Therefore, ovulation does not take place. Chronic anovulation is a common
cause of infertility. Anovulation usually manifests itself as irregularity of menstrual
periods, that is, unpredictable variability of intervals, duration, or bleeding.
Anovulation can also cause cessation of periods (secondary amenorrhea) or excessive
bleeding (dysfunctional uterine bleeding).
The primary cause of infertility is anovulation accounting for 30% which frequently
manifests as oligomenorrhea and amenorrhea. Ovarian factor contributes 30-40% of
infertility cases among women.
In modern science, various treatments are available for ovulation induction but all
have unsatisfactory results and complications. So there is a great scope of research to
find out safe potent remedy for the management of Anovulation.
However, there is lack of specific treatment for anovulation, necessitating the
development of a protocol that specifically addresses this issue.
Due to above mentioned reasons and by understanding the impact of anovulation in
women’s life an attempt is made to have effective ayurvedic treatment regime. |