A clinical trial to study the efficacy of Dashamooladi Shodhanbasti - Ayurveda panchakarma procedure - in patients with Artavakshaya i.e.Amenorrhoea,scanty and infrequent menstruation

Phase 2

Not yet recruiting

Conditions: Amenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, (2) ICD-10 Condition: N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, (3) ICD-10 Condition: N910||Primary amenorrhea. Ayurveda Condition: ARTAVAKSHAYAH, (4) ICD-10 Condition: N911||Secondary amenorrhea. Ayurveda Condition: ARTAVAKSHAYAH,

Registration Number: CTRI/2023/09/057947

Lead Sponsor: Ayurved Mahavidyalaya

Brief Summary: Prevalence of Artavakshaya( Amenorrhoea) is 1.5 to 3 % of female population of reproductive age group. Panchakarma procedure Bastikarma helps to regularise the menstrual cycle. Bastikarma might offer a pure , safe, fast and effective treatment modality. So keeping in mind the ayurvedic basic principles of beejashuddhi this study is to assess the usefulness and effectiveness of dashamooladi shodhanabasti in Artavakshaya patients.

Research question : is dashamooladi shodhanabasti as yogbasti of 8 bastis will be effective in patients suffering from artavakshaya?

Ho: Dashamooladi Shodhanabasti as yogbasti of 8 bastis is not effective in patients suffering from artavakshaya.

H1 : Dashamooladi Shodhanabasti as yogbasti of 8 bastis is effective in patients suffering from artavakshaya.

AIM : To study the Efficacy of Dashamooladi Shodhanabasti in artavakshaya patients.

Objectives : 1.To study the efficacy of Dashamooladi Shodhanabasti in artavakshaya patients . 2to note the other beneficial effects of bastichikitsa on body as a whole. 3. to note adverse effects of the treatment if any.4. Disease and drug review.

Data collection will be done .

Data analysis and statistical tests application will be done.

Results and discussion will be followed by unbiased conclusion.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Patients suffering from menstrual irregularity as Artavakshaya or Rajaksheenata.
Patients having primary or secondary amenorrhoea as a symptom.
3.Patients with artavakshaya willing for conception.
Patients from 16 to 45 years of age.

Exclusion Criteria

Patients having haemorrhagic disorders.
Patients with congenital & developmental defects of genital tract.
Patients with any new growth especially of reproductive system.
Patients with known HIV infection & other venereal diseases.
Patients having major systemic disorders like diabetes mellitus, tuberculosis,asthama, etc.
Pregnant & lactating womens.
Patients unfit for the treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Rajasrava ( Discharge ) Duration	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
2. Rajasrava( Discharge ) Quantity in terms of pads	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
3. Intermenstrual period ( Interval between two cycles)	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
4. Pains during menses	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
5. Follicle Size	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
6. Endometrial thickness	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
7. Changes in Hormonal assays.	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
8. Improvement in haemoglobin percentage.	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months
9. Changes in weight of the patient.	1. Rajasrava ( Discharge ) Duration -3 months \| 2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months \| 3. Intermenstrual period - 3 Months \| 4. Pains during menses - 3 Months \| 5. Follicle Size -3 Months \| 6. Endometrial thickness - 3 Months \| 7. Changes in Hormonal assays- 3 Months \| 8. Improvement in haemoglobin percentage - 3 Months \| 9. Changes in weight of the patient- 3 months

Secondary Outcome Measures

Name	Time	Method
1.Rajasrava ( Discharge ) Duration	2. Rajasrava( Discharge ) Quantity in terms of pads

Trial Locations

Locations (2): Ayurvidya Prasarak Mandals Ayurvedic Mahavidyalaya
🇮🇳
Mumbai, MAHARASHTRA, India
Loknete Rajarambapu Patil Ayurvedic Medical College Hospital P G Institutea and Research Centre
🇮🇳
Sangli, MAHARASHTRA, India
Ayurvidya Prasarak Mandals Ayurvedic Mahavidyalaya
🇮🇳Mumbai, MAHARASHTRA, India
Dr Salim Mulla
Principal investigator
7588627408
drsmmulla@hotmail.com