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Clinical Trial On Testing Efficacy & Safety For 2 Siddha Formulations For Functional Constipation

EVALUATION OF EFFICACY & SAFETY OF TWO SIDDHA FORMULATIONS FOR THE TREATMENT OF FUNCTIONAL CONSTIPATION â?? A COMPARITIVE RANDOMIZED CLINICAL TRIAL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017831
Enrollment
60
Registered
2019-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: Sivathai Chooranam - 5 gm OD at Night: Siddha Medicine combinataion of Syzygium aromaticum Terminalia chebula Emblica officinale Terminalia bellarica Zingiber officinale Piper nigr

Sponsors

Central Council For Research In Siddha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age range between 19 â?? 65 years 2.People meeting the Rome III Diagnostic Criteria 3.Must include two or more of the following: a.Straining during at least 25% of defecation b.Lumpy or hard stools in at least 25 % of defecation c.Sensation of incomplete evacuation for at least 25% of defecation d.Sensation of ano-rectal obstruction/blockage for at least 25% of defecation e.Manual maneuvers to facilitate at least 25% of defecation (e.g., digital evacuation, support of the pelvic floor) f.Fewer than three defecation per week 4.Loose stools are rarely present without the use of laxatives 5.Insufficient criteria for irritable bowel syndrome 6.Patient with stool form score ranging 1-2 Bristol Stool Form Scale 7.People willing to undergo intervention and cooperate with investigations.

Exclusion criteria

Exclusion criteria: 1.Patients on Chronic laxative medication ( > 60 day) 2.Medications known to cause constipation a.Opioid Analgesics b. Antidepressants c.Anti Convulsants d.Aluminium containing Antacids 3.Functional gastro intestinal disorders a.Belching Disorders b.Irritable Bowel Syndrome c.Haemorrhoids 4.H/O Abdominal Surgery in the past 1 year 5.H/O Ano-Rectal Surgery in the past 1 year 6.H/O any Structural Abnormalities in GI tract 7.H/O Chronic DM Medications 8.H/O Chronic HT Medications 9.H/O Renal Dysfunction (KFT Abnormalities) 10.H/O Liver Dysfunction (LFT Abnormalities) 11.H/O Thyroid Disorders and Medications 12.Smoking and alcohol consumption 13.Drug withdrawal within past 6 months 14.H/O Neurological Problems a.Multiple Sclerosis b.Parkinsonâ??s Disease c.Paraplegia d.Sacral Nerve Damage 15.Lactating women

Design outcomes

Primary

MeasureTime frame
30 % increase of Participantâ??s Bowel movement will be expected after completion of study. Timepoint: 30 % increase of Participantâ??s Bowel movement will be expected after completion of study.

Secondary

MeasureTime frame
increase of patient quality of life will be expected after completion of study. This can be measured by using the PA assessment of constipation quality of life questionnaire)Timepoint: increase of patient quality of life will be expected after completion of study. This can be measured by using the PA assessment of constipation quality of life questionnaire)

Countries

India

Contacts

Public ContactManickavasagam Rengaraju

Siddha Clinical Research Unit Under Central Council For Research In Siddha

nismanick@gmail.com09884166739

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026